All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2000
FDA approved the original submission of 105 new drug and biologics license applications in 2000, from 77 sponsors. FDA marks 39 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| DETROL LA | tolterodine tartrate | UPJOHN | NDA021228 | |
| STARLIX | nateglinide | NOVARTIS | NDA021204 | |
| BENZACLIN | benzoyl peroxide, clindamycin phosphate | BAUSCH | NDA050756 | |
| BUSPAR | buspirone hydrochloride | BRISTOL MYERS SQUIBB | NDA021190 | |
| CYCLESSA | desogestrel, ethinyl estradiol | ASPEN GLOBAL INC | NDA021090 | |
| ANGIOMAX | bivalirudin | SANDOZ | NDA020873 | |
| TAMIFLU | oseltamivir phosphate | ROCHE | NDA021246 | |
| LOTRISONE | betamethasone dipropionate, clotrimazole | MERCK SHARP DOHME | NDA020010 | |
| MYOBLOC | botulinum toxin type b | ELAN PHARM | BLA103846 | |
| PROTOPIC | tacrolimus | LEO PHARMA AS | NDA050777 | |
| MIRENA | levonorgestrel | BAYER HLTHCARE | NDA021225 | |
| IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride, simethicone | KENVUE BRANDS | NDA021140 | |
| AKTIPAK | benzoyl peroxide, erythromycin | BIOFRONTERA | NDA050769 | |
| CLINDAGEL | clindamycin phosphate | BAUSCH | NDA050782 | |
| MICARDIS HCT | hydrochlorothiazide, telmisartan | BOEHRINGER INGELHEIM | NDA021162 | |
| TRIZIVIR | abacavir sulfate, lamivudine, zidovudine | VIIV HLTHCARE | NDA021205 | |
| VENOFER | iron sucrose | AM REGENT | NDA021135 | |
| VIDEX EC | didanosine | BRISTOL MYERS SQUIBB | NDA021183 | |
| CARAC | fluorouracil | EXTROVIS | NDA020985 | |
| PEPCID COMPLETE | calcium carbonate, famotidine, magnesium hydroxide | KENVUE BRANDS | NDA020958 | |
| SOLARAZE | diclofenac sodium | FOUGERA | NDA021005 | |
| GLUCOPHAGE XR | metformin hydrochloride | EMD SERONO INC | NDA021202 | |
| NOVANTRONE | mitoxantrone hydrochloride | SERONO INC | NDA021120 | |
| NEURONTIN | gabapentin | PARKE DAVIS | NDA021216 | |
| LESCOL XL | fluvastatin sodium | SANDOZ | NDA021192 | |
| LUNELLE | estradiol cypionate, medroxyprogesterone acetate | PHARMACIA AND UPJOHN | NDA020874 | |
| FLOVENT DISKUS 250 | fluticasone propionate | GLAXO GRP LTD | NDA020833 | |
| TAZORAC | tazarotene | ALMIRALL | NDA021184 | |
| MIFEPREX | mifepristone | DANCO LABS LLC | NDA020687 | |
| TRISENOX | arsenic trioxide | CEPHALON | NDA021248 | |
| VISICOL | sodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrate | SALIX PHARMS | NDA021097 | |
| OVIDREL | choriogonadotropin alfa | EMD SERONO | BLA021149 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021226 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021251 | |
| QVAR 80 | beclomethasone dipropionate | TEVA BRANDED PHARM | NDA020911 | |
| ATACAND HCT | candesartan cilexetil, hydrochlorothiazide | ANI PHARMS | NDA021093 | |
| RENOVA | tretinoin | VALEANT PHARMS NORTH | NDA021108 | |
| ROXICODONE | oxycodone hydrochloride | SPECGX LLC | NDA021011 | |
| RAPAMUNE | sirolimus | PF PRISM CV | NDA021110 | |
| ADVAIR DISKUS 500/50 | fluticasone propionate, salmeterol xinafoate | GLAXO GRP LTD | NDA021077 | |
| UNITHROID | levothyroxine sodium | STEVENS J | NDA021210 | |
| AZULFIDINE EN-TABS | sulfasalazine | PHARMACIA UPJOHN | NDA021243 | |
| QUIXIN | levofloxacin | SANTEN | NDA021199 | |
| VIVELLE | estradiol | NOVARTIS | NDA021167 | |
| CETROTIDE | cetrorelix acetate | EMD SERONO INC | NDA021197 | |
| PULMICORT RESPULES | budesonide | ASTRAZENECA | NDA020929 | |
| DEPAKOTE ER | divalproex sodium | ABBVIE | NDA021168 | |
| RESCULA | unoprostone isopropyl | SUCAMPO PHARMA LLC | NDA021214 | |
| CHILDREN'S MOTRIN COLD | ibuprofen, pseudoephedrine hydrochloride | KENVUE BRANDS | NDA021128 | |
| CONCERTA | methylphenidate hydrochloride | JANSSEN PHARMS | NDA021121 | |
| GLUCOVANCE | glyburide, metformin hydrochloride | BRISTOL MYERS SQUIBB | NDA021178 | |
| CEFAZOLIN AND DEXTROSE | cefazolin sodium | B BRAUN | NDA050779 | |
| VANIQA | eflornithine hydrochloride | ABBVIE | NDA021145 | |
| ABREVA | docosanol | HALEON US HOLDINGS | NDA020941 | |
| COLAZAL | balsalazide disodium | VALEANT PHARMS INTL | NDA020610 | |
| CHLORAPREP ONE-STEP | chlorhexidine gluconate, isopropyl alcohol | BECTON DICKINSON CO | NDA020832 | |
| INNOHEP | tinzaparin sodium | LEO PHARMA AS | NDA020484 | |
| MALARONE PEDIATRIC | atovaquone, proguanil hydrochloride | GLAXOSMITHKLINE | NDA021078 | |
| RENAGEL | sevelamer hydrochloride | GENZYME | NDA021179 | |
| ARGATROBAN | argatroban | SANDOZ | NDA020883 | |
| TARGRETIN | bexarotene | BAUSCH | NDA021056 | |
| NORDITROPIN FLEXPRO | somatropin | NOVO NORDISK INC | BLA021148 | |
| TRELSTAR | triptorelin pamoate | VERITY | NDA020715 | |
| NOVOLOG PENFILL | insulin aspart recombinant | NOVO NORDISK INC | BLA020986 | |
| TNKASE | tenecteplase | GENENTECH | BLA103909 | |
| DIFFERIN | adapalene | GALDERMA LABS LP | NDA020748 | |
| OLUX | clobetasol propionate | QUAGEN | NDA021142 | |
| WELCHOL | colesevelam hydrochloride | COSETTE | NDA021141 | |
| WELCHOL | colesevelam hydrochloride | COSETTE | NDA021176 | |
| OPTIVAR | azelastine hydrochloride | RISING | NDA021127 | |
| INFUVITE ADULT | alpha-tocopherol acetate, ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a palmitate, vitamin k | SANDOZ CANADA INC | NDA021163 | |
| NITROSTAT | nitroglycerin | VIATRIS | NDA021134 | |
| EXELON | rivastigmine tartrate | NOVARTIS | NDA020823 | |
| EXELON | rivastigmine tartrate | NOVARTIS | NDA021025 | |
| LANTUS SOLOSTAR | insulin glargine recombinant | SANOFI AVENTIS US | BLA021081 | |
| ZYVOX | linezolid | PFIZER | NDA021130 | |
| ZYVOX | linezolid | PFIZER | NDA021131 | |
| ZYVOX | linezolid | PFIZER | NDA021132 | |
| MOBIC | meloxicam | BOEHRINGER INGELHEIM | NDA020938 | |
| TRIVAGIZOLE 3 | clotrimazole | SUN PHARMA CANADA | NDA021143 | |
| VISUDYNE | verteporfin | BAUSCH LOMB IRELAND | NDA021119 | |
| ACTIVELLA | estradiol, norethindrone acetate | NOVO NORDISK | NDA021103 | |
| HECTOROL | doxercalciferol | SANOFI | NDA021027 | |
| ZYPREXA ZYDIS | olanzapine | CHEPLAPHARM | NDA021086 | |
| SEPTOCAINE | articaine hydrochloride, epinephrine bitartrate | DEPROCO | NDA020971 | |
| ZONEGRAN | zonisamide | ADVANZ PHARMA | NDA020789 | |
| LAMISIL AT | terbinafine hydrochloride | KARO HLTHCARE | NDA021124 | |
| MAGNEVIST | gadopentetate dimeglumine | BAYER HLTHCARE | NDA021037 | |
| RID MOUSSE | piperonyl butoxide, pyrethrins | BAYER HEALTHCARE LLC | NDA021043 | |
| BIAXIN XL | clarithromycin | ABBVIE | NDA050775 | |
| VIADUR | leuprolide acetate | ORTHO MCNEIL JANSSEN | NDA021088 | |
| NEURONTIN | gabapentin | VIATRIS | NDA021129 | |
| ANDROGEL | testosterone | BESINS HLTHCARE | NDA021015 | |
| ALLEGRA HIVES | fexofenadine hydrochloride | CHATTEM SANOFI | NDA020872 | |
| BETAXON | levobetaxolol hydrochloride | ALCON PHARMS LTD | NDA021114 | |
| BETAPACE AF | sotalol hydrochloride | LEGACY | NDA021151 | |
| SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS | perfluoropolymethylisopropyl ether, polytetrafluoroethylene | US ARMY MED RES | NDA021084 | |
| LOTRONEX | alosetron hydrochloride | LEGACY | NDA021107 | |
| ALLERNAZE | triamcinolone acetonide | LUPIN ATLANTIS | NDA020120 | |
| PROTONIX | pantoprazole sodium | WYETH PHARMS | NDA020987 | |
| CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | calcium chloride | HOSPIRA | NDA021117 | |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | BIOVAIL | NDA020939 | |
| PRIMSOL | trimethoprim hydrochloride | PANGEA | NDA074973 | |
| TRILEPTAL | oxcarbazepine | NOVARTIS | NDA021014 | |
| EVOXAC | cevimeline hydrochloride | COSETTE | NDA020989 |