All FDA drug approvals
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FDA drug approvals — brands starting with A
511 FDA applications with an approved original submission carry a brand starting with A, the earliest approved in 1940 and the most recent in 2026. FDA marks 223 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| A.P.L. | gonadotropin, chorionic | FERRING | BLA017055 | |
| ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate, lamivudine | PHARMOBEDIENT | NDA204311 | |
| ABELCET | amphotericin b | LEADIANT BIOSCI INC | NDA050724 | |
| ABILIFY | aripiprazole | OTSUKA | NDA021436 | |
| ABILIFY | aripiprazole | OTSUKA | NDA021713 | |
| ABILIFY | aripiprazole | OTSUKA | NDA021729 | |
| ABILIFY | aripiprazole | OTSUKA | NDA021866 | |
| ABILIFY ASIMTUFII | aripiprazole | OTSUKA | NDA217006 | |
| ABILIFY MAINTENA KIT | aripiprazole | OTSUKA PHARM CO LTD | NDA202971 | |
| ABILIFY MYCITE KIT | aripiprazole | OTSUKA | NDA207202 | |
| ABLAVAR | gadofosveset trisodium | LANTHEUS MEDCL | NDA021711 | |
| ABLYSINOL | dehydrated alcohol | BPI LABS | NDA207987 | |
| ABRAXANE | paclitaxel | BRISTOL-MYERS | NDA021660 | |
| ABREVA | docosanol | HALEON US HOLDINGS | NDA020941 | |
| ABRILADA | adalimumab-afzb | PFIZER INC | BLA761118 | |
| ABSORICA | isotretinoin | SUN PHARM INDS INC | NDA021951 | |
| ABSORICA LD | isotretinoin | SUN PHARM | NDA211913 | |
| ABSTRAL | fentanyl citrate | SENTYNL THERAPS INC | NDA022510 | |
| ACANYA | benzoyl peroxide, clindamycin phosphate | BAUSCH | NDA050819 | |
| ACCOLATE | zafirlukast | STRIDES PHARMA INTL | NDA020547 | |
| ACCRETROPIN | somatropin | EMERGENT | BLA021538 | |
| ACCRUFER | ferric maltol | SHIELD TX | NDA212320 | |
| ACCUNEB | albuterol sulfate | PHARMOBEDIENT | NDA020949 | |
| ACCUPRIL | quinapril hydrochloride | PFIZER PHARMS | NDA019885 | |
| ACCURETIC | hydrochlorothiazide, quinapril hydrochloride | PFIZER PHARMS | NDA020125 | |
| ACCUTANE | isotretinoin | HOFFMANN LA ROCHE | NDA018662 | |
| ACEON | perindopril erbumine | SYMPLMED PHARMS LLC | NDA020184 | |
| ACEPHEN | acetaminophen | COSETTE | NDA018060 | |
| ACETADOTE | acetylcysteine | APOTEX | NDA021539 | |
| ACETAMINOPHEN | acetaminophen | TARO | NDA018337 | |
| ACETAMINOPHEN | acetaminophen | FRESENIUS KABI USA | NDA204767 | |
| ACETAMINOPHEN | acetaminophen | B BRAUN MEDICAL | NDA204957 | |
| ACETAMINOPHEN | acetaminophen | RISING | NDA206610 | |
| ACETAMINOPHEN | acetaminophen | HIKMA | NDA206968 | |
| ACETATED RINGER'S IN PLASTIC CONTAINER | calcium chloride, potassium chloride, sodium acetate, sodium chloride | B BRAUN | NDA018725 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | acetic acid, glacial | OTSUKA ICU MEDCL | NDA017656 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | acetic acid, glacial | B BRAUN | NDA018161 | |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | acetic acid, glacial | BAXTER HLTHCARE | NDA018523 | |
| ACHROMYCIN | tetracycline hydrochloride | STORZ | NDA050266 | |
| ACHROMYCIN | tetracycline hydrochloride | STORZ | NDA050268 | |
| ACHROMYCIN | hydrocortisone, tetracycline hydrochloride | LEDERLE | NDA050272 | |
| ACHROMYCIN | tetracycline hydrochloride | LEDERLE | NDA050273 | |
| ACHROMYCIN | procaine hydrochloride, tetracycline hydrochloride | LEDERLE | NDA050276 | |
| ACHROMYCIN V | tetracycline hydrochloride | LEDERLE | NDA050263 | |
| ACHROMYCIN V | tetracycline hydrochloride | AVET | NDA050278 | |
| ACIPHEX | rabeprazole sodium | WAYLIS THERAP | NDA020973 | |
| ACIPHEX | rabeprazole sodium | EISAI MEDCL RES | NDA021456 | |
| ACIPHEX SPRINKLE | rabeprazole sodium | AYTU | NDA204736 | |
| ACLOVATE | alclometasone dipropionate | FOUGERA | NDA018702 | |
| ACLOVATE | alclometasone dipropionate | FOUGERA | NDA018707 | |
| ACTEMRA | tocilizumab | GENENTECH | BLA125276 | |
| ACTEMRA | tocilizumab | GENENTECH | BLA125472 | |
| ACTH | corticotropin | PARKEDALE | NDA008317 | |
| ACTHAR | corticotropin | SANOFI AVENTIS US | NDA007504 | |
| ACTHAR GEL | corticotropin | MALLINCKRODT IRELAND | NDA008372 | |
| ACTHREL | corticorelin ovine triflutate | FERRING | BLA020162 | |
| ACTICLATE | doxycycline hyclate | CHARTWELL RX | NDA205931 | |
| ACTICLATE CAP | doxycycline hyclate | CHARTWELL RX | NDA208253 | |
| ACTIGALL | ursodiol | TEVA BRANDED PHARM | NDA019594 | |
| ACTIMMUNE | interferon gamma-1b | HORIZON THERAPEUTICS IRELAND DAC | BLA103836 | |
| ACTINEX | masoprocol | UNIV AZ CANCER CTR | NDA019940 | |
| ACTIQ | fentanyl citrate | CEPHALON | NDA020747 | |
| ACTISITE | tetracycline hydrochloride | SCHIFF AND CO | NDA050653 | |
| ACTIVASE | alteplase | GENENTECH | BLA103172 | |
| ACTIVELLA | estradiol, norethindrone acetate | AMNEAL | NDA020907 | |
| ACTIVELLA | estradiol, norethindrone acetate | NOVO NORDISK | NDA021103 | |
| ACTIVELLA | estradiol, norethindrone acetate | NOVO NORDISK INC | NDA022001 | |
| ACTONEL | risedronate sodium | APIL | NDA020835 | |
| ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate, risedronate sodium | WARNER CHILCOTT | NDA021823 | |
| ACTOPLUS MET | metformin hydrochloride, pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA021842 | |
| ACTOPLUS MET XR | metformin hydrochloride, pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA022024 | |
| ACTOS | pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA021073 | |
| ACTRON | ketoprofen | BAYER | NDA020499 | |
| ACULAR | ketorolac tromethamine | ABBVIE | NDA019700 | |
| ACULAR LS | ketorolac tromethamine | ABBVIE | NDA021528 | |
| ACULAR PRESERVATIVE FREE | ketorolac tromethamine | ALLERGAN | NDA020811 | |
| ACUTECT | technetium tc-99m apcitide | CIS BIO INTL SA | NDA020887 | |
| ACUVAIL | ketorolac tromethamine | ABBVIE | NDA022427 | |
| ACUVUE THERAVISION WITH KETOTIFEN | ketotifen fumarate | JOHNSON JOHNSON VISN | NDA022388 | |
| ACZONE | dapsone | ALMIRALL | NDA021794 | |
| ACZONE | dapsone | ALMIRALL | NDA207154 | |
| ADAGEN | pegademase bovine | LEADIANT BIOSCI INC | BLA019818 | |
| ADAKVEO | crizanlizumab-tmca | NOVARTIS PHARMS CORP | BLA761128 | |
| ADALAT | nifedipine | BAYER PHARMS | NDA019478 | |
| ADALAT CC | nifedipine | NORWICH | NDA020198 | |
| ADASUVE | loxapine | NOVA PNEUMA | NDA022549 | |
| ADBRY | tralokinumab | LEO PHARMA AS | BLA761180 | |
| ADCETRIS | brentuximab vedotin | SEATTLE GENETICS | BLA125388 | |
| ADCETRIS | brentuximab vedotin | SEATTLE GENETICS | BLA125399 | |
| ADCIRCA | tadalafil | ELI LILLY CO | NDA022332 | |
| ADDERALL 5 | amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate | TEVA WOMENS | NDA011522 | |
| ADDERALL XR 10 | amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate | TAKEDA PHARMS USA | NDA021303 | |
| ADDYI | flibanserin | SPROUT PHARMS | NDA022526 | |
| ADEMPAS | riociguat | BAYER HLTHCARE | NDA204819 | |
| ADENOCARD | adenosine | ASTELLAS | NDA019937 | |
| ADENOSCAN | adenosine | ASTELLAS | NDA020059 | |
| ADHANSIA XR | methylphenidate hydrochloride | KNOA PHARMA | NDA212038 | |
| ADLARITY | donepezil hydrochloride | CORIUM | NDA212304 | |
| ADLYXIN | lixisenatide | SANOFI-AVENTIS US | BLA208471 | |
| ADMELOG | insulin lispro | SANOFI-AVENTIS US | BLA209196 | |
| ADQUEY | difamilast | ACROTECH BIOPHARMA | NDA219474 | |
| ADRENACLICK | epinephrine | IMPAX | NDA020800 | |
| ADRENALIN | epinephrine | PH HEALTH | NDA204200 | |
| ADRENALIN | epinephrine | PH HEALTH | NDA204640 | |
| ADRENALIN | epinephrine | PH HEALTH | NDA215875 | |
| ADREVIEW | iobenguane sulfate i-123 | GE HEALTHCARE | NDA022290 | |
| ADUHELM | aducanumab-avwa | BIOGEN INC | BLA761178 | |
| ADVAIR DISKUS 500/50 | fluticasone propionate, salmeterol xinafoate | GLAXO GRP LTD | NDA021077 | |
| ADVAIR HFA | fluticasone propionate, salmeterol xinafoate | GLAXO GRP LTD | NDA021254 | |
| ADVIL | ibuprofen | HALEON US HOLDINGS | NDA018989 | |
| ADVIL | ibuprofen sodium | HALEON US HOLDINGS | NDA201803 | |
| ADVIL ALLERGY AND CONGESTION RELIEF | chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride | HALEON US HOLDINGS | NDA022113 | |
| ADVIL ALLERGY SINUS | chlorpheniramine maleate, ibuprofen, pseudoephedrine hydrochloride | HALEON US HOLDINGS | NDA021441 | |
| ADVIL COLD AND SINUS | ibuprofen, pseudoephedrine hydrochloride | HALEON US HOLDINGS | NDA019771 | |
| ADVIL COLD AND SINUS | ibuprofen, pseudoephedrine hydrochloride | HALEON US HOLDINGS | NDA021374 | |
| ADVIL CONGESTION RELIEF | ibuprofen, phenylephrine hydrochloride | HALEON US HOLDINGS | NDA022565 | |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen, ibuprofen | HALEON US HOLDINGS | NDA211733 | |
| ADVIL LIQUI-GELS | ibuprofen | HALEON US HOLDINGS | NDA020402 | |
| ADVIL PM | diphenhydramine hydrochloride, ibuprofen | HALEON US HOLDINGS | NDA021393 | |
| ADVIL PM | diphenhydramine citrate, ibuprofen | HALEON US HOLDINGS | NDA021394 | |
| ADZENYS ER | amphetamine | NEOS THERAPS INC | NDA204325 | |
| ADZENYS XR-ODT | amphetamine | NEOS THERAPS | NDA204326 | |
| AEMCOLO | rifamycin sodium | COSMO TECHNOLOGIES | NDA210910 | |
| AEROBID | flunisolide | ROCHE PALO | NDA018340 | |
| AEROSPAN HFA | flunisolide | PHARMOBEDIENT | NDA021247 | |
| AFINITOR | everolimus | NOVARTIS | NDA022334 | |
| AFINITOR DISPERZ | everolimus | NOVARTIS PHARM | NDA203985 | |
| AFREZZA | insulin recombinant human | MANNKIND | BLA022472 | |
| AFRINOL | pseudoephedrine sulfate | SCHERING PLOUGH | NDA018191 | |
| AGAMREE | vamorolone | CATALYST PHARMS | NDA215239 | |
| AGENERASE | amprenavir | GLAXOSMITHKLINE | NDA021007 | |
| AGENERASE | amprenavir | GLAXOSMITHKLINE | NDA021039 | |
| AGGRASTAT | tirofiban hydrochloride | MEDICURE | NDA020912 | |
| AGGRASTAT | tirofiban hydrochloride | MEDICURE | NDA020913 | |
| AGGRENOX | aspirin, dipyridamole | BOEHRINGER INGELHEIM | NDA020884 | |
| AGRYLIN | anagrelide hydrochloride | TAKEDA PHARMS USA | NDA020333 | |
| AHZANTIVE | aflibercept-mrbb | FORMYCON AG | BLA761378 | |
| AIMOVIG | erenumab-aooe | AMGEN INC | BLA761077 | |
| AIR | air | GENERAL AIR SERVICE & SUPPLY COMPANY | NDA221287 | |
| AIR | air | NOBLE GAS SOLUTIONS INC. | NDA221805 | |
| AIRDUO DIGIHALER | fluticasone propionate, salmeterol xinafoate | TEVA PHARM | NDA208799 | |
| AIRSUPRA | albuterol sulfate, budesonide | ASTRAZENECA | NDA214070 | |
| AJOVY | fremanezumab-vfrm | TEVA PHARMS USA | BLA761089 | |
| AK-FLUOR 25% | fluorescein sodium | LONG GROVE PHARMS | NDA022186 | |
| AKEEGA | abiraterone acetate, niraparib tosylate | JANSSEN BIOTECH | NDA216793 | |
| AKINETON | biperiden hydrochloride | ABBVIE | NDA012003 | |
| AKINETON | biperiden lactate | ABBVIE | NDA012418 | |
| AKLIEF | trifarotene | GALDERMA LABS LP | NDA211527 | |
| AKNE-MYCIN | erythromycin | BAUSCH | NDA050584 | |
| AKOVAZ | ephedrine sulfate | EXELA PHARMA | NDA208289 | |
| AKTEN | lidocaine hydrochloride | THEA PHARMA | NDA022221 | |
| AKTIPAK | benzoyl peroxide, erythromycin | BIOFRONTERA | NDA050769 | |
| AKYNZEO | netupitant, palonosetron hydrochloride | HELSINN HLTHCARE | NDA205718 | |
| AKYNZEO | fosnetupitant chloride hydrochloride, palonosetron hydrochloride | HELSINN HLTHCARE | NDA210493 | |
| ALAMAST | pemirolast potassium | SANTEN | NDA021079 | |
| ALAVERT | loratadine | FDN CONSUMER | NDA021375 | |
| ALBAMYCIN | novobiocin sodium | PHARMACIA AND UPJOHN | NDA050339 | |
| ALBENZA | albendazole | IMPAX LABS INC | NDA020666 | |
| ALCOHOL 5% AND DEXTROSE 5% | alcohol, dextrose | B BRAUN | NDA004589 | |
| ALDACTAZIDE | hydrochlorothiazide, spironolactone | PFIZER | NDA012616 | |
| ALDACTONE | spironolactone | PFIZER | NDA012151 | |
| ALDARA | imiquimod | BAUSCH | NDA020723 | |
| ALDOCLOR-250 | chlorothiazide, methyldopa | MERCK | NDA016016 | |
| ALDOMET | methyldopa | MERCK | NDA013400 | |
| ALDOMET | methyldopate hydrochloride | MERCK | NDA013401 | |
| ALDOMET | methyldopa | MERCK | NDA018389 | |
| ALDORIL 15 | hydrochlorothiazide, methyldopa | MERCK | NDA013402 | |
| ALDURAZYME | laronidase | BIOMARIN | BLA125058 | |
| ALECENSA | alectinib hydrochloride | HOFFMANN-LA ROCHE | NDA208434 | |
| ALESSE | ethinyl estradiol, levonorgestrel | CADENCE HEALTH | NDA020683 | |
| ALEVE | naproxen sodium | BAYER | NDA020204 | |
| ALEVE PM | diphenhydramine hydrochloride, naproxen sodium | BAYER HLTHCARE | NDA205352 | |
| ALEVE-D SINUS & COLD | naproxen sodium, pseudoephedrine hydrochloride | BAYER | NDA021076 | |
| ALFENTA | alfentanil hydrochloride | RISING | NDA019353 | |
| ALFERON N INJECTION | interferon alfa-n3 | INTERFERON SCIENCES | BLA103158 | |
| ALHEMO | concizumab-mtci | NOVO NORDISK INC | BLA761315 | |
| ALHEMO | concizumab | NOVO NORDISK INC | BLA761428 | |
| ALIMTA | pemetrexed disodium | LILLY | NDA021462 | |
| ALIMTA | pemetrexed | LILLY | NDA021677 | |
| ALINIA | nitazoxanide | ROMARK | NDA021497 | |
| ALINIA | nitazoxanide | ROMARK | NDA021498 | |
| ALINIA | nitazoxanide | ROMARK | NDA021818 | |
| ALIQOPA | copanlisib dihydrochloride | BAYER HEALTHCARE | NDA209936 | |
| ALKERAN | melphalan | APOTEX | NDA014691 | |
| ALKERAN | melphalan hydrochloride | APOTEX | NDA020207 | |
| ALKINDI SPRINKLE | hydrocortisone | ETON | NDA213876 | |
| ALLEGRA | fexofenadine hydrochloride | CHATTEM SANOFI | NDA020625 | |
| ALLEGRA | fexofenadine hydrochloride | CHATTEM SANOFI | NDA021963 | |
| ALLEGRA HIVES | fexofenadine hydrochloride | CHATTEM SANOFI | NDA020872 | |
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride, pseudoephedrine hydrochloride | CHATTEM SANOFI | NDA020786 | |
| ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride, pseudoephedrine hydrochloride | CHATTEM SANOFI | NDA021704 | |
| ALLERNAZE | triamcinolone acetonide | LUPIN ATLANTIS | NDA020120 | |
| ALLI | orlistat | HALEON US HOLDINGS | NDA021887 | |
| ALLOPURINOL | allopurinol | WATSON LABS | NDA018832 | |
| ALLOPURINOL | allopurinol | WATSON LABS | NDA018877 | |
| ALOCRIL | nedocromil sodium | ALLERGAN | NDA021009 | |
| ALOMIDE | lodoxamide tromethamine | NOVARTIS | NDA020191 | |
| ALOPRIM | allopurinol sodium | MYLAN | NDA020298 | |
| ALORA | estradiol | ABBVIE | NDA020655 | |
| ALORA | estradiol | WATSON LABS | NDA021310 | |
| ALOXI | palonosetron hydrochloride | HELSINN HLTHCARE | NDA021372 | |
| ALOXI | palonosetron hydrochloride | HELSINN HLTHCARE | NDA022233 | |
| ALPHAGAN | brimonidine tartrate | ALLERGAN | NDA020490 | |
| ALPHAGAN | brimonidine tartrate | ALLERGAN | NDA020613 | |
| ALPHAGAN P | brimonidine tartrate | ABBVIE | NDA021262 | |
| ALPHAGAN P | brimonidine tartrate | ABBVIE | NDA021770 | |
| ALPHATREX | betamethasone dipropionate | SAVAGE LABS | NDA019138 | |
| ALPHATREX | betamethasone dipropionate | SAVAGE LABS | NDA019143 | |
| ALREX | loteprednol etabonate | BAUSCH AND LOMB | NDA020803 | |
| ALSUMA | sumatriptan succinate | MERIDIAN MEDCL | NDA022377 | |
| ALTABAX | retapamulin | ALMIRALL | NDA022055 | |
| ALTACE | ramipril | KING PHARMS LLC | NDA019901 | |
| ALTACE | ramipril | KING PFIZER | NDA022021 | |
| ALTAFLUOR BENOX | benoxinate hydrochloride, fluorescein sodium | ALTAIRE PHARMS INC | NDA208582 | |
| ALTOPREV | lovastatin | AZURITY | NDA021316 | |
| ALTRENO | tretinoin | DOW PHARM | NDA209353 | |
| ALUNBRIG | brigatinib | TAKEDA PHARMS USA | NDA208772 | |
| ALUPENT | metaproterenol sulfate | BOEHRINGER INGELHEIM | NDA015874 | |
| ALUPENT | metaproterenol sulfate | BOEHRINGER INGELHEIM | NDA016402 | |
| ALUPENT | metaproterenol sulfate | BOEHRINGER INGELHEIM | NDA017571 | |
| ALUPENT | metaproterenol sulfate | BOEHRINGER INGELHEIM | NDA017659 | |
| ALUPENT | metaproterenol sulfate | BOEHRINGER INGELHEIM | NDA018761 | |
| ALVAIZ | eltrombopag choline | TEVA PHARMS INC | NDA216774 | |
| ALVESCO | ciclesonide | AZURITY | NDA021658 | |
| ALYFTREK | deutivacaftor, tezacaftor, vanzacaftor calcium | VERTEX PHARMS INC | NDA218730 | |
| ALYMSYS | bevacizumab-maly | AMNEAL PHARMS LLC | BLA761231 | |
| AMARYL | glimepiride | SANOFI AVENTIS US | NDA020496 | |
| AMBELVIST | gadoquatrane | BAYER HEALTHCARE | NDA219627 | |
| AMBENYL | bromodiphenhydramine hydrochloride, codeine phosphate | FOREST LABS | NDA009319 | |
| AMBIEN | zolpidem tartrate | COSETTE | NDA019908 | |
| AMBIEN CR | zolpidem tartrate | COSETTE | NDA021774 | |
| AMBISOME | amphotericin b | ASTELLAS | NDA050740 | |
| AMELUZ | aminolevulinic acid hydrochloride | BIOFRONTERA | NDA208081 | |
| AMERGE | naratriptan hydrochloride | GLAXOSMITHKLINE LLC | NDA020763 | |
| AMERSCAN MDP KIT | technetium tc-99m medronate kit | GE HEALTHCARE | NDA018335 | |
| AMICAR | aminocaproic acid | HIKMA | NDA015197 | |
| AMICAR | aminocaproic acid | EPIC PHARMA LLC | NDA015229 | |
| AMICAR | aminocaproic acid | HIKMA | NDA015230 | |
| AMIDATE | etomidate | HOSPIRA | NDA018227 | |
| AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE | amino acids | HOSPIRA | NDA018901 | |
| AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER | glycine | BAXTER HLTHCARE | NDA017865 | |
| AMINOCAPROIC ACID | aminocaproic acid | BAXTER HLTHCARE | NDA018590 | |
| AMINOHIPPURATE SODIUM | aminohippurate sodium | MERCK | NDA005619 | |
| AMINOPHYLLIN | aminophylline | GD SEARLE LLC | NDA002386 | |
| AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | aminophylline | HOSPIRA | NDA018924 | |
| AMINOSYN 10% (PH6) | amino acids, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, potassium phosphate, dibasic | ICU MEDICAL INC | NDA017673 | |
| AMINOSYN 3.5% M | amino acids, magnesium acetate, phosphoric acid, potassium acetate, sodium chloride, magnesium chloride, potassium phosphate, dibasic | ICU MEDICAL INC | NDA017789 | |
| AMINOSYN II 10% | amino acids | ICU MEDICAL INC | NDA019438 | |
| AMINOSYN II 10% IN PLASTIC CONTAINER | amino acids | OTSUKA ICU MEDCL | NDA020015 | |
| AMINOSYN II 15% IN PLASTIC CONTAINER | amino acids | OTSUKA ICU MEDCL | NDA020041 | |
| AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER | amino acids, dextrose | HOSPIRA | NDA019681 | |
| AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER | amino acids, dextrose, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, heptahydrate, potassium phosphate, dibasic | ABBOTT | NDA019564 | |
| AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER | amino acids, dextrose, magnesium chloride, potassium acetate, potassium chloride, potassium phosphate, dibasic, sodium chloride, sodium phosphate, dibasic, heptahydrate | HOSPIRA INC | NDA019682 | |
| AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER | amino acids, dextrose | ABBOTT | NDA019565 | |
| AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | amino acids, calcium chloride, dextrose, magnesium chloride, potassium chloride, potassium phosphate, dibasic, sodium chloride | HOSPIRA INC | NDA019683 | |
| AMINOSYN II 8.5% W/ELECTROLYTES | amino acids, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, potassium phosphate, dibasic, sodium phosphate, dibasic, heptahydrate | ICU MEDICAL INC | NDA019437 | |
| AMINOSYN-HBC 7% | amino acids | ICU MEDICAL INC | NDA019374 | |
| AMINOSYN-PF 10% | amino acids | OTSUKA ICU MEDCL | NDA019492 | |
| AMINOSYN-PF 7% | amino acids | OTSUKA ICU MEDCL | NDA019398 | |
| AMINOSYN-RF 5.2% | amino acids | ICU MEDICAL INC | NDA018429 | |
| AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | INTL MEDICATION SYS | NDA021594 | |
| AMIPAQUE | metrizamide | GE HEALTHCARE | NDA017982 | |
| AMITIZA | lubiprostone | SUCAMPO PHARMA LLC | NDA021908 | |
| AMJEVITA | adalimumab-atto | AMGEN INC | BLA761024 | |
| AMLEXANOX | amlexanox | ULURU | NDA021727 | |
| AMLODIPINE BESYLATE | amlodipine besylate | SYNTHON PHARMS | NDA022026 | |
| AMMONIA N 13 | ammonia n-13 | FEINSTEIN | NDA022119 | |
| AMMONUL | sodium benzoate, sodium phenylacetate | BAUSCH | NDA020645 | |
| AMONDYS 45 | casimersen | SAREPTA THERAPS INC | NDA213026 | |
| AMOXIL | amoxicillin | GLAXOSMITHKLINE | NDA050459 | |
| AMOXIL | amoxicillin | GLAXOSMITHKLINE | NDA050460 | |
| AMOXIL | amoxicillin | US ANTIBIOTICS | NDA050542 | |
| AMOXIL | amoxicillin | US ANTIBIOTICS | NDA050754 | |
| AMOXIL | amoxicillin | US ANTIBIOTICS | NDA050760 | |
| AMOXIL | amoxicillin | US ANTIBIOTICS | NDA050761 | |
| AMPHADASE | hyaluronidase | AMPHASTAR PHARM | BLA021665 | |
| AMPHOTEC | amphotericin b | ALKOPHARMA USA | NDA050729 | |
| AMPYRA | dalfampridine | MERZ | NDA022250 | |
| AMRIX | cyclobenzaprine hydrochloride | TEVA PHARMS INTL | NDA021777 | |
| AMTURNIDE | aliskiren hemifumarate, amlodipine besylate, hydrochlorothiazide | NOVARTIS | NDA200045 | |
| AMVAZ | amlodipine maleate | DR REDDYS LABS INC | NDA021435 | |
| AMVUTTRA | vutrisiran sodium | ALNYLAM PHARMS INC | NDA215515 | |
| AMYVID | florbetapir f-18 | AVID RADIOPHARMS INC | NDA202008 | |
| AMZEEQ | minocycline hydrochloride | JOURNEY | NDA212379 | |
| AN-DTPA | technetium tc-99m pentetate kit | JUBILANT DRAXIMAGE | NDA017714 | |
| AN-SULFUR COLLOID | technetium tc-99m sulfur colloid kit | SUN PHARM INDS INC | NDA017858 | |
| ANADROL-50 | oxymetholone | PHARMOBEDIENT | NDA016848 | |
| ANAFRANIL | clomipramine hydrochloride | SPECGX LLC | NDA019906 | |
| ANAPROX DS | naproxen sodium | ATNAHS PHARMA US | NDA018164 | |
| ANCEF | cefazolin sodium | GLAXOSMITHKLINE | NDA050461 | |
| ANCOBON | flucytosine | BAUSCH | NDA017001 | |
| ANDEMBRY | garadacimab-gxii | CSL BEHRING LLC | BLA761367 | |
| ANDRODERM | testosterone | ABBVIE | NDA020489 | |
| ANDROGEL | testosterone | BESINS HLTHCARE | NDA021015 | |
| ANDROGEL | testosterone | BESINS HLTHCARE | NDA022309 | |
| ANECTINE | succinylcholine chloride | SANDOZ | NDA008453 | |
| ANGELIQ | drospirenone, estradiol | BAYER HLTHCARE | NDA021355 | |
| ANGIO-CONRAY | iothalamate sodium | MALLINCKRODT | NDA013319 | |
| ANGIOMAX | bivalirudin | SANDOZ | NDA020873 | |
| ANGIOMAX RTU | bivalirudin | MAIA PHARMS INC | NDA211215 | |
| ANHYDRON | cyclothiazide | LILLY | NDA013157 | |
| ANJESO | meloxicam | BAUDAX | NDA210583 | |
| ANKTIVA | nogapendekin alfa inbakicept-pmln | ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU | BLA761336 | |
| ANNOVERA | ethinyl estradiol, segesterone acetate | MAYNE PHARMA | NDA209627 | |
| ANORO ELLIPTA | umeclidinium bromide, vilanterol trifenatate | GLAXOSMITHKLINE | NDA203975 | |
| ANSAID | flurbiprofen | PHARMACIA AND UPJOHN | NDA018766 | |
| ANTABUSE | disulfiram | TEVA WOMENS | NDA007883 | |
| ANTARA (MICRONIZED) | fenofibrate | LUPIN | NDA021695 | |
| ANTEPAR | piperazine citrate | GLAXOSMITHKLINE | NDA009102 | |
| ANTHELIOS 20 | avobenzone, ecamsule, octocrylene, titanium dioxide | LOREAL USA | NDA021471 | |
| ANTHELIOS 40 | avobenzone, ecamsule, octocrylene, titanium dioxide | LOREAL USA | NDA022009 | |
| ANTHELIOS SX | avobenzone, ecamsule, octocrylene | LOREAL USA | NDA021502 | |
| ANTHIM | obiltoxaximab | ELUSYS THERAPEUTICS INC | BLA125509 | |
| ANTIVERT | meclizine hydrochloride | CASPER PHARMA LLC | NDA010721 | |
| ANTIZOL | fomepizole | PAR PHARM INC | NDA020696 | |
| ANTURANE | sulfinpyrazone | NOVARTIS | NDA011556 | |
| ANZEMET | dolasetron mesylate | VALIDUS PHARMS | NDA020623 | |
| ANZEMET | dolasetron mesylate | VALIDUS PHARMS | NDA020624 | |
| ANZUPGO | delgocitinib | LEO PHARMA AS | NDA219155 | |
| APADAZ | acetaminophen, benzhydrocodone hydrochloride | ZEVRA THERAP | NDA208653 | |
| APHEXDA | motixafortide acetate | AYRMID PHARMA | NDA217159 | |
| APHTHASOL | amlexanox | ULURU | NDA020511 | |
| APIDRA SOLOSTAR | insulin glulisine recombinant | SANOFI AVENTIS US | BLA021629 | |
| APLENZIN | bupropion hydrobromide | BAUSCH | NDA022108 | |
| APOKYN | apomorphine hydrochloride | MDD US | NDA021264 | |
| APONVIE | aprepitant | HERON THERAPS INC | NDA216457 | |
| APREPITANT | aprepitant | AZURITY | NDA218754 | |
| APRESOLINE | hydralazine hydrochloride | NOVARTIS | NDA008303 | |
| APRETUDE | cabotegravir | VIIV HLTHCARE | NDA215499 | |
| APRISO | mesalamine | SALIX | NDA022301 | |
| APTENSIO XR | methylphenidate hydrochloride | RHODES PHARMS | NDA205831 | |
| APTIOM | eslicarbazepine acetate | SUMITOMO PHARMA AM | NDA022416 | |
| APTIVUS | tipranavir | BOEHRINGER INGELHEIM | NDA021814 | |
| APTIVUS | tipranavir | BOEHRINGER INGELHEIM | NDA021822 | |
| APTIVUS | tipranavir | BOEHRINGER INGELHEIM | NDA022292 | |
| AQNEURSA | levacetylleucine | INTRABIO | NDA219132 | |
| AQUAMEPHYTON | phytonadione | PAI HOLDINGS PHARM | NDA012223 | |
| AQUASOL A | vitamin a palmitate | CASPER PHARMA LLC | NDA006823 | |
| AQUATAG | benzthiazide | SOLVAY | NDA016001 | |
| AQUATENSEN | methyclothiazide | MEDPOINTE PHARM HLC | NDA017364 | |
| ARAKODA | tafenoquine succinate | 60 DEGREES PHARMS | NDA210607 | |
| ARALEN | chloroquine phosphate, chloroquine hydrochloride | SANOFI AVENTIS US | NDA006002 | |
| ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE | chloroquine phosphate, primaquine phosphate | SANOFI AVENTIS US | NDA014860 | |
| ARAMINE | metaraminol bitartrate | MERCK | NDA009509 | |
| ARANESP | darbepoetin alfa | AMGEN | BLA103951 | |
| ARAVA | leflunomide | SANOFI AVENTIS US | NDA020905 | |
| ARAZLO | tazarotene | BAUSCH | NDA211882 | |
| ARBLI | losartan potassium | SCIENTURE | NDA218772 | |
| ARCALYST | rilonacept | KINIKSA PHARMACEUTICALS (UK), LTD. | BLA125249 | |
| ARCAPTA NEOHALER | indacaterol maleate | NOVARTIS | NDA022383 | |
| ARDUAN | pipecuronium bromide | ORGANON USA INC | NDA019638 | |
| AREDIA | pamidronate disodium | NOVARTIS | NDA020036 | |
| AREDIA | pamidronate disodium | NOVARTIS | NDA020927 | |
| ARESTIN | minocycline hydrochloride | ORAPHARMA | NDA050781 | |
| ARFONAD | trimethaphan camsylate | ROCHE | NDA008983 | |
| ARGATROBAN | argatroban | SANDOZ | NDA020883 | |
| ARGATROBAN | argatroban | FRESENIUS KABI USA | NDA201811 | |
| ARGATROBAN | argatroban | HIKMA PHARM CO LTD | NDA203049 | |
| ARGATROBAN IN 0.9% SODIUM CHLORIDE | argatroban | TEVA PHARMS USA | NDA206769 | |
| ARGATROBAN IN DEXTROSE | argatroban | SANDOZ | NDA201743 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | CIPLA | NDA022434 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | PLANO PHARMS | NDA022485 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | EUGIA PHARMA SPECLTS | NDA209552 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | ACCORD HLTHCARE | NDA212035 | |
| ARICEPT | donepezil hydrochloride | EISAI INC | NDA020690 | |
| ARICEPT | donepezil hydrochloride | EISAI INC | NDA021719 | |
| ARICEPT | donepezil hydrochloride | EISAI INC | NDA022568 | |
| ARICEPT ODT | donepezil hydrochloride | EISAI INC | NDA021720 | |
| ARIDOL KIT | mannitol | PHARMAXIS EUROPE | NDA022368 | |
| ARIKAYCE KIT | amikacin sulfate | INSMED INC | NDA207356 | |
| ARIMIDEX | anastrozole | ANI PHARMS | NDA020541 | |
| ARIMIDEX | anastrozole | ASTRAZENECA | NDA022214 | |
| ARISTADA | aripiprazole lauroxil | ALKERMES INC | NDA207533 | |
| ARISTADA INITIO KIT | aripiprazole lauroxil | ALKERMES INC | NDA209830 | |
| ARISTOCORT | triamcinolone | ASTELLAS | NDA011161 | |
| ARISTOCORT | triamcinolone diacetate | FOSUN PHARMA | NDA011685 | |
| ARISTOCORT | triamcinolone diacetate | ASTELLAS | NDA011960 | |
| ARISTOCORT | triamcinolone diacetate | FOSUN PHARMA | NDA012802 | |
| ARISTOSPAN | triamcinolone hexacetonide | ETHYPHARM | NDA016466 | |
| ARIXTRA | fondaparinux sodium | MYLAN IRELAND LTD | NDA021345 | |
| ARMLUPEG | pegfilgrastim-unne | LUPIN LTD | BLA761212 | |
| ARMONAIR RESPICLICK | fluticasone propionate | TEVA PHARM | NDA208798 | |
| ARNUITY ELLIPTA | fluticasone furoate | GLAXOSMITHKLINE | NDA205625 | |
| AROMASIN | exemestane | PFIZER | NDA020753 | |
| ARRANON | nelarabine | SANDOZ | NDA021877 | |
| ARTANE | trihexyphenidyl hydrochloride | LEDERLE | NDA006773 | |
| ARTANE | trihexyphenidyl hydrochloride | LEDERLE | NDA012947 | |
| ARTESUNATE | artesunate | AMIVAS | NDA213036 | |
| ARTHROTEC | diclofenac sodium, misoprostol | PFIZER | NDA020607 | |
| ARYMO ER | morphine sulfate | ZYLA | NDA208603 | |
| ARYNTA | lisdexamfetamine dimesylate | AZURITY | NDA219847 | |
| ASACOL | mesalamine | APIL | NDA019651 | |
| ASACOL HD | mesalamine | ABBVIE | NDA021830 | |
| ASCLERA | polidocanol | CHEMISCH FBRK KRSSLR | NDA021201 | |
| ASCOR | ascorbic acid | MCGUFF | NDA209112 | |
| ASENDIN | amoxapine | LEDERLE | NDA018021 | |
| ASMANEX HFA | mometasone furoate | ORGANON LLC | NDA205641 | |
| ASMANEX TWISTHALER | mometasone furoate | ORGANON LLC | NDA021067 | |
| ASPARLAS | calaspargase pegol-mknl | SERVIER PHARMA LLC | BLA761102 | |
| ASPRUZYO SPRINKLE | ranolazine | SPIL | NDA216018 | |
| ASTAGRAF XL | tacrolimus | ASTELLAS | NDA204096 | |
| ASTELIN | azelastine hydrochloride | RISING | NDA020114 | |
| ASTEPRO | azelastine hydrochloride | VIATRIS | NDA022203 | |
| ASTEPRO | azelastine hydrochrloride | MEDA PHARMS | NDA022371 | |
| ASTEPRO ALLERGY | azelastine hydrochloride | BAYER HLTHCARE | NDA213872 | |
| ATACAND | candesartan cilexetil | ANI PHARMS | NDA020838 | |
| ATACAND HCT | candesartan cilexetil, hydrochlorothiazide | ANI PHARMS | NDA021093 | |
| ATARAX | hydroxyzine hydrochloride | PFIZER | NDA010392 | |
| ATARAX | hydroxyzine hydrochloride | ROERIG | NDA010485 | |
| ATELVIA | risedronate sodium | APIL | NDA022560 | |
| ATIVAN | lorazepam | BAUSCH | NDA017794 | |
| ATIVAN | lorazepam | HIKMA | NDA018140 | |
| ATMEKSI | methocarbamol | ROSEMONT PHARMS | NDA219843 | |
| ATNAA | atropine, pralidoxime chloride | US ARMY | NDA021175 | |
| ATONCY | atomoxetine hydrochloride | MAP77 | NDA220320 | |
| ATORVALIQ | atorvastatin calcium | CMP DEV LLC | NDA213260 | |
| ATRALIN | tretinoin | DOW PHARM | NDA022070 | |
| ATRIDOX | doxycycline hyclate | DEN-MAT | NDA050751 | |
| ATRIPLA | efavirenz, emtricitabine, tenofovir disoproxil fumarate | GILEAD SCIENCES | NDA021937 | |
| ATROMID-S | clofibrate | WYETH AYERST | NDA016099 | |
| ATROPEN | atropine | MMT | NDA017106 | |
| ATROPINE (AUTOINJECTOR) | atropine | RAFA LABS LTD | NDA212319 | |
| ATROPINE SULFATE | atropine sulfate | US ARMY | NDA020056 | |
| ATROPINE SULFATE | atropine sulfate | HOSPIRA | NDA021146 | |
| ATROPINE SULFATE | atropine sulfate | RISING | NDA206289 | |
| ATROPINE SULFATE | atropine sulfate | FRESENIUS KABI USA | NDA209260 | |
| ATROPINE SULFATE | atropine sulfate | BAUSCH AND LOMB INC | NDA213581 | |
| ATROPINE SULFATE | atropine sulfate | ACCORD HLTHCARE | NDA214652 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA019085 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA020228 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA020393 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA020394 | |
| ATROVENT HFA | ipratropium bromide | BOEHRINGER INGELHEIM | NDA021527 | |
| ATTRUBY | acoramidis hydrochloride | BRIDGEBIO PHARMA | NDA216540 | |
| ATZUMI | dihydroergotamine mesylate | SATSUMA PHARMS | NDA217901 | |
| AUBAGIO | teriflunomide | SANOFI AVENTIS US | NDA202992 | |
| AUGMENTIN '125' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050575 | |
| AUGMENTIN '125' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050597 | |
| AUGMENTIN '200' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050726 | |
| AUGMENTIN '250' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050564 | |
| AUGMENTIN '400' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050725 | |
| AUGMENTIN '875' | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050720 | |
| AUGMENTIN ES-600 | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050755 | |
| AUGMENTIN XR | amoxicillin, clavulanate potassium | US ANTIBIOTICS | NDA050785 | |
| AUGTYRO | repotrectinib | BRISTOL | NDA218213 | |
| AUKELSO | denosumab-kyqq | BIOCON BIOLOGICS INC | BLA761436 | |
| AUREOMYCIN | chlortetracycline hydrochloride | LEDERLE | NDA050404 | |
| AURLUMYN | iloprost | BTG INTL | NDA217933 | |
| AURYXIA | ferric citrate | KERYX BIOPHARMS | NDA205874 | |
| AUSTEDO | deutetrabenazine | TEVA BRANDED PHARM | NDA208082 | |
| AUSTEDO | deutetrabenazine | TEVA BRANDED PHARM | NDA209885 | |
| AUSTEDO XR | deutetrabenazine | TEVA | NDA216354 | |
| AUVELITY | bupropion hydrochloride, dextromethorphan hydrobromide | AXSOME | NDA215430 | |
| AUVI-Q | epinephrine | KALEO INC | NDA201739 | |
| AVACLYR | acyclovir | FERA PHARMS LLC | NDA202408 | |
| AVAGARD | alcohol, chlorhexidine gluconate | SOLVENTUM | NDA021074 | |
| AVALIDE | hydrochlorothiazide, irbesartan | SANOFI AVENTIS US | NDA020758 | |
| AVANDAMET | metformin hydrochloride, rosiglitazone maleate | SB PHARMCO | NDA021410 | |
| AVANDARYL | glimepiride, rosiglitazone maleate | SB PHARMCO | NDA021700 | |
| AVANDIA | rosiglitazone maleate | WOODWARD | NDA021071 | |
| AVAPRO | irbesartan | SANOFI AVENTIS US | NDA020757 | |
| AVASTIN | bevacizumab | GENENTECH | BLA125085 | |
| AVC | sulfanilamide | PHARMOBEDIENT | NDA006530 | |
| AVEED | testosterone undecanoate | ENDO OPERATIONS | NDA022219 | |
| AVELOX | moxifloxacin hydrochloride | BAYER HLTHCARE | NDA021085 | |
| AVELOX | moxifloxacin hydrochloride | BAYER PHARMS | NDA021334 | |
| AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | BAYER HLTHCARE | NDA021277 | |
| AVENTYL | nortriptyline hydrochloride | RANBAXY | NDA014685 | |
| AVENTYL HYDROCHLORIDE | nortriptyline hydrochloride | LILLY | NDA014684 | |
| AVGEMSI | gemcitabine hydrochloride | AVYXA HOLDINGS | NDA219920 | |
| AVINZA | morphine sulfate | KING PHARMS LLC | NDA021260 | |
| AVITA | tretinoin | RISING | NDA020400 | |
| AVITA | tretinoin | MYLAN PHARMS INC | NDA020404 | |
| AVLAYAH | tividenofusp alfa-eknm | DENALI THERAPEUTICS INC. | BLA761485 | |
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | avutometinib potassium, defactinib hydrochloride | VERASTEM INC | NDA219616 | |
| AVODART | dutasteride | WAYLIS THERAP | NDA021319 | |
| AVONEX | interferon beta-1a | BIOGEN | BLA103628 | |
| AVOPEF | etoposide | AVYXA HOLDINGS | NDA220200 | |
| AVSOLA | infliximab-axxq | AMGEN INC | BLA761086 | |
| AVTOZMA | tocilizumab-anoh | CELLTRION INC | BLA761420 | |
| AVTOZMA | tocilizumab-anoh | CELLTRION INC | BLA761498 | |
| AVYCAZ | avibactam sodium, ceftazidime | ABBVIE | NDA206494 | |
| AVZIVI | bevacizumab-tnjn | BIO-THERA SOLUTIONS LTD | BLA761198 | |
| AWIQLI FLEXTOUCH | insulin icodec | NOVO NORDISK INC | BLA761326 | |
| AXERT | almotriptan malate | JANSSEN PHARMS | NDA021001 | |
| AXID | nizatidine | SMITHKLINE BEECHAM | NDA019508 | |
| AXID | nizatidine | BRAINTREE | NDA021494 | |
| AXID AR | nizatidine | HALEON US HOLDINGS | NDA020555 | |
| AXIRON | testosterone | ELI LILLY AND CO | NDA022504 | |
| AXTLE | pemetrexed dipotassium | AVYXA HOLDINGS | NDA210661 | |
| AXUMIN | fluciclovine f-18 | BLUE EARTH | NDA208054 | |
| AYGESTIN | norethindrone acetate | DURAMED RES | NDA018405 | |
| AYVAKIT | avapritinib | BLUEPRINT MEDICINES | NDA212608 | |
| AZACITIDINE | azacitidine | ACTAVIS LLC | NDA208216 | |
| AZACTAM | aztreonam | LABS DELBERT | NDA050580 | |
| AZACTAM IN PLASTIC CONTAINER | aztreonam | BRISTOL MYERS SQUIBB | NDA050632 | |
| AZASITE | azithromycin | THEA PHARMA | NDA050810 | |
| AZEDRA | iobenguane i-131 | PROGENICS PHARMS INC | NDA209607 | |
| AZELEX | azelaic acid | ALMIRALL | NDA020428 | |
| AZILECT | rasagiline mesylate | TEVA | NDA021641 | |
| AZITHROMYCIN | azithromycin | TEVA PARENTERAL | NDA050809 | |
| AZMACORT | triamcinolone acetonide | ABBVIE | NDA018117 | |
| AZMIRO | testosterone cypionate | AZURITY | NDA216318 | |
| AZO GANTRISIN | phenazopyridine hydrochloride, sulfisoxazole | ROCHE | NDA019358 | |
| AZOPT | brinzolamide | SANDOZ | NDA020816 | |
| AZOR | amlodipine besylate, olmesartan medoxomil | COSETTE | NDA022100 | |
| AZSTARYS | dexmethylphenidate hydrochloride, serdexmethylphenidate chloride | COMMAVE SUB | NDA212994 | |
| AZULFIDINE | sulfasalazine | PHARMACIA AND UPJOHN | NDA018605 | |
| AZULFIDINE | sulfasalazine | PHARMACIA AND UPJOHN | NDA020465 | |
| AZULFIDINE EN-TABS | sulfasalazine | PFIZER | NDA007073 | |
| AZULFIDINE EN-TABS | sulfasalazine | PHARMACIA UPJOHN | NDA021243 |