All FDA drug approvals
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FDA drug approvals — brands starting with B
219 FDA applications with an approved original submission carry a brand starting with B, the earliest approved in 1939 and the most recent in 2026. FDA marks 95 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | HOSPIRA | NDA018800 | |
| BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | sterile water for injection | HOSPIRA | NDA018802 | |
| BACTOCILL IN PLASTIC CONTAINER | oxacillin sodium | BAXTER HLTHCARE | NDA050640 | |
| BACTRIM | sulfamethoxazole, trimethoprim | SUN PHARM INDUSTRIES | NDA017377 | |
| BACTRIM | sulfamethoxazole, trimethoprim | SUN PHARM INDUSTRIES | NDA017560 | |
| BACTRIM | sulfamethoxazole, trimethoprim | SUN PHARM INDS INC | NDA018374 | |
| BACTROBAN | mupirocin | GLAXOSMITHKLINE | NDA050591 | |
| BACTROBAN | mupirocin calcium | GLAXOSMITHKLINE | NDA050703 | |
| BACTROBAN | mupirocin calcium | GLAXOSMITHKLINE | NDA050746 | |
| BAFIERTAM | monomethyl fumarate | BANNER LIFE SCIENCES | NDA210296 | |
| BAL | dimercaprol | PROVEPHARM SAS | NDA005939 | |
| BALCOLTRA | ethinyl estradiol, levonorgestrel | AVION PHARMS | NDA208612 | |
| BALVERSA | erdafitinib | JANSSEN BIOTECH | NDA212018 | |
| BANAN | cefpodoxime proxetil | SANKYO | NDA050687 | |
| BANAN | cefpodoxime proxetil | SANKYO | NDA050688 | |
| BANTHINE | methantheline bromide | SHIRE | NDA007390 | |
| BANZEL | rufinamide | EISAI INC | NDA021911 | |
| BANZEL | rufinamide | EISAI INC | NDA201367 | |
| BAQSIMI | glucagon | AMPHASTAR PHARMS INC | NDA210134 | |
| BARACLUDE | entecavir | BRISTOL MYERS SQUIBB | NDA021797 | |
| BARACLUDE | entecavir | BRISTOL MYERS SQUIBB | NDA021798 | |
| BARHEMSYS | amisulpride | LXO IRELAND | NDA209510 | |
| BAROS | sodium bicarbonate, tartaric acid | MALLINCKRODT INC | NDA018509 | |
| BASAGLAR | insulin glargine | ELI LILLY AND CO | BLA205692 | |
| BAVENCIO | avelumab | EMD SERONO INC | BLA761049 | |
| BAVENCIO | avelumab | EMD SERONO INC | BLA761078 | |
| BAXDELA | delafloxacin meglumine | MELINTA | NDA208610 | |
| BAXDELA | delafloxacin meglumine | MELINTA | NDA208611 | |
| BAXFENDY | baxdrostat | ASTRAZENECA AB | NDA219878 | |
| BAYCOL | cerivastatin sodium | BAYER PHARMS | NDA020740 | |
| BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN | aspirin | BAYER | NDA021317 | |
| BECLOVENT | beclomethasone dipropionate | GLAXOSMITHKLINE | NDA018153 | |
| BECONASE | beclomethasone dipropionate | GLAXOSMITHKLINE | NDA018584 | |
| BECONASE AQ | beclomethasone dipropionate monohydrate | GLAXOSMITHKLINE | NDA019389 | |
| BEIZRAY | docetaxel | ZHUHAI | NDA218711 | |
| BELBUCA | buprenorphine hydrochloride | BDSI | NDA207932 | |
| BELEODAQ | belinostat | ACROTECH BIOPHARMA | NDA206256 | |
| BELRAPZO | bendamustine hydrochloride | EAGLE PHARMS | NDA205580 | |
| BELSOMRA | suvorexant | MERCK SHARP DOHME | NDA204569 | |
| BENADRYL | diphenhydramine hydrochloride | MCNEIL CONS | NDA005845 | |
| BENADRYL | diphenhydramine hydrochloride | MCNEIL CONS | NDA006146 | |
| BENADRYL PRESERVATIVE FREE | diphenhydramine hydrochloride | MCNEIL CONS | NDA009486 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | HOSPIRA | NDA211530 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | APOTEX | NDA215033 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | BAXTER HLTHCARE CORP | NDA216078 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | AVYXA HOLDINGS | NDA219014 | |
| BENDECTIN | doxylamine succinate, pyridoxine hydrochloride | SANOFI AVENTIS US | NDA010598 | |
| BENDEKA | bendamustine hydrochloride | EAGLE PHARMS | NDA208194 | |
| BENEMID | probenecid | MERCK | NDA007898 | |
| BENICAR | olmesartan medoxomil | COSETTE | NDA021286 | |
| BENICAR HCT | hydrochlorothiazide, olmesartan medoxomil | COSETTE | NDA021532 | |
| BENLYSTA | belimumab | HUMAN GENOME SCIENCES INC. | BLA125370 | |
| BENLYSTA | belimumab | GLAXOSMITHKLINE LLC | BLA761043 | |
| BENOQUIN | monobenzone | VALEANT PHARM INTL | NDA008173 | |
| BENSULFOID | sulfur | POYTHRESS | NDA002918 | |
| BENTYL | dicyclomine hydrochloride | ALLERGAN | NDA007409 | |
| BENTYL | dicyclomine hydrochloride | APTALIS PHARMA US | NDA007961 | |
| BENTYL | dicyclomine hydrochloride | ABBVIE | NDA008370 | |
| BENZACLIN | benzoyl peroxide, clindamycin phosphate | BAUSCH | NDA050756 | |
| BENZAMYCIN | benzoyl peroxide, erythromycin | VALEANT INTL | NDA050557 | |
| BENZNIDAZOLE | benznidazole | CHEMO RESEARCH SL | NDA209570 | |
| BEOVU | brolucizumab-dbll | NOVARTIS PHARMS CORP | BLA761125 | |
| BEPADIN | bepridil hydrochloride | MEDPOINTE PHARM HLC | NDA019001 | |
| BEPREVE | bepotastine besilate | BAUSCH AND LOMB INC | NDA022288 | |
| BEQALZI | sonrotoclax | BEONE MEDICINES USA | NDA220711 | |
| BEROCCA PN | ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a palmitate, vitamin e | ROCHE | NDA006071 | |
| BESIVANCE | besifloxacin hydrochloride | BAUSCH AND LOMB | NDA022308 | |
| BESPONSA | inotuzumab ozogamicin | WYETH PHARMS INC | BLA761040 | |
| BESREMI | ropeginterferon alfa-2b-njft | PHARMAESSENTIA CORP | BLA761166 | |
| BETA-VAL | betamethasone valerate | COSETTE PHARMS NC | NDA018642 | |
| BETADERM | betamethasone valerate | ROACO | NDA018839 | |
| BETADINE | povidone-iodine | ALCON PHARMS LTD | NDA018634 | |
| BETAGAN | levobunolol hydrochloride | ALLERGAN | NDA019219 | |
| BETAGAN | levobunolol hydrochloride | ALLERGAN | NDA019814 | |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | FOUGERA | NDA019137 | |
| BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | FOUGERA | NDA019141 | |
| BETAMETHASONE VALERATE | betamethasone valerate | FOUGERA | NDA018861 | |
| BETAMETHASONE VALERATE | betamethasone valerate | FOUGERA | NDA018865 | |
| BETAMETHASONE VALERATE | betamethasone valerate | FOUGERA | NDA018866 | |
| BETAPACE | sotalol hydrochloride | LEGACY | NDA019865 | |
| BETAPACE AF | sotalol hydrochloride | LEGACY | NDA021151 | |
| BETAPRONE | propiolactone | FOREST LABS | NDA011657 | |
| BETASERON | interferon beta-1b | BAYER HEALTHCARE PHARMS | BLA103471 | |
| BETATREX | betamethasone valerate | SAVAGE LABS | NDA018862 | |
| BETATREX | betamethasone valerate | SAVAGE LABS | NDA018863 | |
| BETATREX | betamethasone valerate | SAVAGE LABS | NDA018867 | |
| BETAXON | levobetaxolol hydrochloride | ALCON PHARMS LTD | NDA021114 | |
| BETHKIS | tobramycin | CHIESI | NDA201820 | |
| BETIMOL | timolol | THEA PHARMA | NDA020439 | |
| BETOPTIC | betaxolol hydrochloride | SANDOZ | NDA019270 | |
| BETOPTIC PILO | betaxolol hydrochloride, pilocarpine hydrochloride | ALCON | NDA020619 | |
| BETOPTIC S | betaxolol hydrochloride | NOVARTIS | NDA019845 | |
| BEVESPI AEROSPHERE | formoterol fumarate, glycopyrrolate | ASTRAZENECA | NDA208294 | |
| BEVYXXA | betrixaban | PORTOLA PHARMS INC | NDA208383 | |
| BEXTRA | valdecoxib | GD SEARLE | NDA021341 | |
| BEYAZ | drospirenone, ethinyl estradiol, levomefolate calcium | BAYER HLTHCARE | NDA022532 | |
| BEYFORTUS | nirsevimab-alip | ASTRAZENECA AB | BLA761328 | |
| BIAXIN | clarithromycin | ABBVIE | NDA050662 | |
| BIAXIN | clarithromycin | ABBVIE | NDA050698 | |
| BIAXIN XL | clarithromycin | ABBVIE INC | NDA050697 | |
| BIAXIN XL | clarithromycin | ABBVIE | NDA050775 | |
| BICILLIN | penicillin g benzathine | WYETH AYERST | NDA050126 | |
| BICILLIN C-R | penicillin g benzathine, penicillin g procaine | KING PHARMS LLC | NDA050138 | |
| BICILLIN L-A | penicillin g benzathine | WYETH AYERST | NDA050131 | |
| BICILLIN L-A | penicillin g benzathine | KING PHARMS LLC | NDA050141 | |
| BICNU | carmustine | AVET LIFESCIENCES | NDA017422 | |
| BIDIL | hydralazine hydrochloride, isosorbide dinitrate | AZURITY | NDA020727 | |
| BIJUVA | estradiol, progesterone | MAYNE PHARMA | NDA210132 | |
| BIKTARVY | bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA210251 | |
| BILOPAQUE | tyropanoate sodium | GE HEALTHCARE | NDA013731 | |
| BILPREVDA | denosumab-nxxp | SHANGHAI HENLIUS BIOTECH | BLA761444 | |
| BILTRICIDE | praziquantel | BAYER HLTHCARE | NDA018714 | |
| BIMZELX | bimekizumab-bkzx | UCB INC | BLA761151 | |
| BINOSTO | alendronate sodium | RADIUS | NDA202344 | |
| BIORPHEN | phenylephrine hydrochloride | DR REDDYS LABS SA | NDA212909 | |
| BIOSCRUB | chlorhexidine gluconate | GRIFFEN | NDA019822 | |
| BIPHETAMINE 7.5 | amphetamine resin complex, dextroamphetamine resin complex | UCB INC | NDA010093 | |
| BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | BAXTER HLTHCARE CORP | NDA208374 | |
| BIXLENVO | bictegravir and lenacapavir | GILEAD SCIENCES | NDA221104 | |
| BIZENGRI | zenocutuzumab-zbco | MERUS N.V. | BLA761352 | |
| BKEMV | eculizumab-aeeb | AMGEN INC | BLA761333 | |
| BLENOXANE | bleomycin sulfate | BRISTOL MYERS SQUIBB | NDA050443 | |
| BLENREP | belantamab mafodotin-blmf | GLAXOSMITHKLINE LLC | BLA761440 | |
| BLEPHAMIDE | prednisolone acetate, sulfacetamide sodium | ALLERGAN | NDA012813 | |
| BLINCYTO | blinatumomab | AMGEN | BLA125557 | |
| BLOCADREN | timolol maleate | MERCK | NDA018017 | |
| BLOXIVERZ | neostigmine methylsulfate | EXELA PHARMA | NDA204078 | |
| BLUDIGO | indigotindisulfonate sodium | PROVEPHARM SAS | NDA216264 | |
| BLUJEPA | gepotidacin mesylate | GLAXOSMITHKLINE | NDA218230 | |
| BONCRESA | denosumab-mobz | AMNEAL PHARMS LLC | BLA761456 | |
| BONDLIDO | lidocaine | MEDRX USA | NDA215029 | |
| BONIVA | ibandronate sodium | HOFFMANN LA ROCHE | NDA021455 | |
| BONIVA | ibandronate sodium | ROCHE | NDA021858 | |
| BONJESTA | doxylamine succinate, pyridoxine hydrochloride | DUCHESNAY | NDA209661 | |
| BONSITY | teriparatide | ALVOGEN | NDA211939 | |
| BORTEZOMIB | bortezomib | FRESENIUS KABI USA | NDA205004 | |
| BORTEZOMIB | bortezomib | DR REDDYS | NDA206927 | |
| BORTEZOMIB | bortezomib | HOSPIRA | NDA209191 | |
| BORTEZOMIB | bortezomib | SHILPA | NDA212782 | |
| BORTEZOMIB | bortezomib | MAIA PHARMS INC | NDA215331 | |
| BORTEZOMIB | bortezomib | ACCORD HLTHCARE | NDA215441 | |
| BOSULIF | bosutinib monohydrate | PF PRISM CV | NDA203341 | |
| BOSULIF | bosutinib monohydrate | PF PRISM CV | NDA217729 | |
| BOTOX COSMETIC | onabotulinumtoxina | ALLERGAN | BLA103000 | |
| BRAFTOVI | encorafenib | ARRAY BIOPHARMA INC | NDA210496 | |
| BRANCHAMIN 4% IN PLASTIC CONTAINER | amino acids | BAXTER HLTHCARE | NDA018684 | |
| BRAVELLE | urofollitropin | FERRING | BLA021289 | |
| BRAVELLE | urofollitropin | FERRING | BLA021484 | |
| BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | AMNEAL | NDA215400 | |
| BRENZAVVY | bexagliflozin | THERACOSBIO | NDA214373 | |
| BREO ELLIPTA | fluticasone furoate, vilanterol trifenatate | GLAXO GRP LTD | NDA204275 | |
| BRETHINE | terbutaline sulfate | ANI PHARMS | NDA017849 | |
| BRETHINE | terbutaline sulfate | PHARMACARE | NDA018571 | |
| BRETYLIUM TOSYLATE | bretylium tosylate | HOSPIRA | NDA019030 | |
| BRETYLIUM TOSYLATE | bretylium tosylate | HOSPIRA | NDA019033 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% | bretylium tosylate | ABBOTT | NDA019005 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | bretylium tosylate | HOSPIRA INC | NDA019008 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | bretylium tosylate | B BRAUN | NDA019121 | |
| BREVIBLOC | esmolol hydrochloride | BAXTER HLTHCARE | NDA019386 | |
| BREVICON 21-DAY | ethinyl estradiol, norethindrone | ALLERGAN | NDA017566 | |
| BREVICON 28-DAY | ethinyl estradiol, norethindrone | ALLERGAN | NDA017743 | |
| BREVITAL SODIUM | methohexital sodium | PH HEALTH | NDA011559 | |
| BREXAFEMME | ibrexafungerp citrate | GLAXOSMITHKLINE | NDA214900 | |
| BREZTRI AEROSPHERE | budesonide, formoterol fumarate, glycopyrrolate | ASTRAZENECA AB | NDA212122 | |
| BRICANYL | terbutaline sulfate | SANOFI AVENTIS US | NDA017466 | |
| BRICANYL | terbutaline sulfate | SANOFI AVENTIS US | NDA017618 | |
| BRICANYL | terbutaline sulfate | SANOFI AVENTIS US | NDA018000 | |
| BRIDION | sugammadex sodium | MSD SUB MERCK | NDA022225 | |
| BRILINTA | ticagrelor | ASTRAZENECA | NDA022433 | |
| BRINEURA | cerliponase alfa | BIOMARIN PHARM | BLA761052 | |
| BRINSUPRI | brensocatib | INSMED INC | NDA217673 | |
| BRISDELLE | paroxetine mesylate | LEGACY | NDA204516 | |
| BRIUMVI | ublituximab-xiiy | TG THERAPEUTICS, INC | BLA761238 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205836 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205837 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205838 | |
| BRIXADI | buprenorphine | BRAEBURN | NDA210136 | |
| BROMDAY | bromfenac sodium | BAUSCH AND LOMB INC | NDA021664 | |
| BROMSITE | bromfenac sodium | SUN PHARM | NDA206911 | |
| BRONCHITOL | mannitol | PHARMAXIS EUROPE | NDA202049 | |
| BRONCHO SALINE | sodium chloride | BLAIREX | NDA019912 | |
| BRONITIN MIST | epinephrine bitartrate, epinephrine | WYETH CONS | NDA016126 | |
| BRONKAID MIST | epinephrine | STERLING | NDA016803 | |
| BROVANA | arformoterol tartrate | LUPIN | NDA021912 | |
| BRUKINSA | zanubrutinib | BEONE MEDICINES USA | NDA213217 | |
| BRUKINSA | zanubrutinib | BEONE MEDICINES USA | NDA218785 | |
| BRYHALI | halobetasol propionate | BAUSCH | NDA209355 | |
| BRYNOVIN | sitagliptin hydrochloride | AZURITY | NDA219122 | |
| BSS | calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate | ALCON | NDA020742 | |
| BSS PLUS | calcium chloride, dextrose, glutathione disulfide, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate | ALCON | NDA018469 | |
| BUCLADIN-S | buclizine hydrochloride | STUART PHARMS | NDA010911 | |
| BUMEX | bumetanide | VALIDUS PHARMS | NDA018225 | |
| BUMEX | bumetanide | VALIDUS PHARMS | NDA018226 | |
| BUNAVAIL | buprenorphine hydrochloride, naloxone hydrochloride | BDSI | NDA205637 | |
| BUPHENYL | sodium phenylbutyrate | HORIZON THERAP US | NDA020572 | |
| BUPHENYL | sodium phenylbutyrate | HORIZON THERAP US | NDA020573 | |
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | HOSPIRA | NDA018053 | |
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride, epinephrine bitartrate | HOSPIRA | NDA022046 | |
| BUPIVACAINE HYDROCHLORIDE KIT | bupivacaine hydrochloride | HOSPIRA | NDA019978 | |
| BUPRENEX | buprenorphine hydrochloride | INDIVIOR | NDA018401 | |
| BUSPAR | buspirone hydrochloride | BRISTOL MYERS SQUIBB | NDA018731 | |
| BUSPAR | buspirone hydrochloride | BRISTOL MYERS SQUIBB | NDA021190 | |
| BUSULFEX | busulfan | OTSUKA PHARM | NDA020954 | |
| BUTAZOLIDIN | phenylbutazone | NOVARTIS | NDA008319 | |
| BUTISOL SODIUM | butabarbital sodium | PHARMOBEDIENT | NDA000793 | |
| BUTOCONAZOLE NITRATE | butoconazole nitrate | PADAGIS US | NDA019881 | |
| BUTRANS | buprenorphine | KNOA PHARMA | NDA021306 | |
| BYDUREON BCISE | exenatide synthetic | ASTRAZENECA AB | NDA209210 | |
| BYDUREON PEN | exenatide synthetic | ASTRAZENECA AB | NDA022200 | |
| BYETTA | exenatide synthetic | ASTRAZENECA AB | NDA021773 | |
| BYETTA | exenatide synthetic | AMYLIN | NDA021919 | |
| BYFAVO | remimazolam besylate | ACACIA | NDA212295 | |
| BYLVAY | odevixibat | IPSEN | NDA215498 | |
| BYNFEZIA PEN | octreotide acetate | SUN PHARM | NDA213224 | |
| BYOOVIZ | ranibizumab-nuna | SAMSUNG BIOEPIS CO LTD | BLA761202 | |
| BYQLOVI | clobetasol propionate | HARROW EYE | NDA218158 | |
| BYSANTI | milsaperidone | VANDA PHARMS INC | NDA220358 | |
| BYSTOLIC | nebivolol hydrochloride | ALLERGAN | NDA021742 | |
| BYVALSON | nebivolol hydrochloride, valsartan | ABBVIE | NDA206302 |