All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 1995
FDA approved the original submission of 89 new drug and biologics license applications in 1995, from 59 sponsors. FDA marks 43 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| NUTROPIN AQ PEN | somatropin | GENENTECH | BLA020522 | |
| RENOVA | tretinoin | VALEANT PHARMS NORTH | NDA019963 | |
| CORVERT | ibutilide fumarate | PFIZER | NDA020491 | |
| ARIMIDEX | anastrozole | ANI PHARMS | NDA020541 | |
| PHOTOFRIN | porfimer sodium | PINNACLE BIOLGS | NDA020451 | |
| LUPRON DEPOT | leuprolide acetate | ABBVIE ENDOCRINE INC | NDA020517 | |
| FEMSTAT 3 | butoconazole nitrate | BAYER | NDA020421 | |
| IONTOCAINE | epinephrine, lidocaine hydrochloride | IOMED | NDA020530 | |
| OXILAN-350 | ioxilan | GUERBET | NDA020316 | |
| CEDAX | ceftibuten dihydrate | BURKE THERAP | NDA050685 | |
| CEDAX | ceftibuten dihydrate | BURKE THERAP | NDA050686 | |
| RETROVIR | zidovudine | VIIV HLTHCARE | NDA020518 | |
| ZANTAC 75 | ranitidine hydrochloride | CHATTEM SANOFI | NDA020520 | |
| ZOLADEX | goserelin | TERSERA | NDA020515 | |
| NIMBEX PRESERVATIVE FREE | cisatracurium besylate | ABBVIE | NDA020551 | |
| VALTREX | valacyclovir hydrochloride | GLAXOSMITHKLINE | NDA020550 | |
| RILUTEK | riluzole | AZURITY | NDA020599 | |
| ETHYOL | amifostine | LEGACY | NDA020221 | |
| ZYRTEC HIVES | cetirizine hydrochloride | KENVUE BRANDS | NDA019835 | |
| INVIRASE | saquinavir mesylate | HOFFMANN LA ROCHE | NDA020628 | |
| AMARYL | glimepiride | SANOFI AVENTIS US | NDA020496 | |
| VESANOID | tretinoin | CHEPLAPHARM | NDA020438 | |
| ABELCET | amphotericin b | LEADIANT BIOSCI INC | NDA050724 | |
| DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | BAXTER HLTHCARE CORP | NDA050718 | |
| EPIVIR | lamivudine | VIIV HLTHCARE | NDA020564 | |
| EPIVIR | lamivudine | VIIV HLTHCARE | NDA020596 | |
| PREMPRO | estrogens, conjugated, medroxyprogesterone acetate | WYETH PHARMS | NDA020527 | |
| TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER | amino acids, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride | BAXTER HLTHCARE | NDA020173 | |
| OMNIPAQUE 350 | iohexol | GE HEALTHCARE | NDA020608 | |
| TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER | amino acids, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride | BAXTER HLTHCARE | NDA020177 | |
| TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER | amino acids, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride | BAXTER HLTHCARE | NDA020147 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA020393 | |
| ATROVENT | ipratropium bromide | BOEHRINGER INGELHEIM | NDA020394 | |
| ZITHROMAX | azithromycin | PFIZER | NDA050710 | |
| ACTRON | ketoprofen | BAYER | NDA020499 | |
| ORUDIS KT | ketoprofen | WYETH CONS | NDA020429 | |
| CASODEX | bicalutamide | ANI PHARMS | NDA020498 | |
| ANDRODERM | testosterone | ABBVIE | NDA020489 | |
| FOSAMAX | alendronate sodium | ORGANON | NDA020560 | |
| DEXTROSE 5% IN PLASTIC CONTAINER | dextrose | DHL | NDA019971 | |
| FLOLAN | epoprostenol sodium | GLAXOSMITHKLINE LLC | NDA020444 | |
| METROCREAM | metronidazole | GALDERMA LABS LP | NDA020531 | |
| BACTROBAN | mupirocin calcium | GLAXOSMITHKLINE | NDA050703 | |
| PROPULSID | cisapride monohydrate | JANSSEN PHARMS | NDA020398 | |
| COREG | carvedilol | WAYLIS THERAP | NDA020297 | |
| AZELEX | azelaic acid | ALMIRALL | NDA020428 | |
| TIAZAC | diltiazem hydrochloride | BAUSCH | NDA020401 | |
| DDAVP | desmopressin acetate | FERRING PHARMS INC | NDA019955 | |
| PRECOSE | acarbose | BAYER HLTHCARE | NDA020482 | |
| DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% | dopamine hydrochloride | HOSPIRA | NDA020542 | |
| GENOTROPIN PRESERVATIVE FREE | somatropin | PHARMACIA | BLA020280 | |
| MIACALCIN | calcitonin salmon | SAPTALIS PHARMS | NDA020313 | |
| CORDARONE | amiodarone hydrochloride | WYETH PHARMS INC | NDA020377 | |
| NEORAL | cyclosporine | NOVARTIS | NDA050715 | |
| NEORAL | cyclosporine | NOVARTIS | NDA050716 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | magnesium sulfate | HOSPIRA | NDA020488 | |
| CAVERJECT | alprostadil | PFIZER | NDA020379 | |
| PRIMSOL | trimethoprim hydrochloride | PANGEA | NDA074374 | |
| VALTREX | valacyclovir hydrochloride | GLAXOSMITHKLINE | NDA020487 | |
| DYNABAC | dirithromycin | LILLY RES LABS | NDA050678 | |
| TAGAMET HB | cimetidine | MEDTECH PRODUCTS | NDA020238 | |
| CHILDREN'S MOTRIN | ibuprofen | KENVUE BRANDS | NDA020516 | |
| ULTANE | sevoflurane | ABBVIE | NDA020478 | |
| IMITREX | sumatriptan succinate | GLAXOSMITHKLINE | NDA020132 | |
| ZINECARD | dexrazoxane hydrochloride | PFIZER | NDA020212 | |
| MOTRIN | ibuprofen | MCNEIL | NDA020476 | |
| ZOMACTON | somatropin | FERRING | BLA019774 | |
| ADENOSCAN | adenosine | ASTELLAS | NDA020059 | |
| PREVACID | lansoprazole | TAKEDA PHARMS USA | NDA020406 | |
| ULTRAVIST 150 | iopromide | BAYER HLTHCARE | NDA020220 | |
| CELLCEPT | mycophenolate mofetil | ROCHE PALO | NDA050722 | |
| FLAGYL | metronidazole | PFIZER | NDA020334 | |
| HYZAAR | hydrochlorothiazide, losartan potassium | ORGANON | NDA020387 | |
| PEPCID AC | famotidine | KENVUE BRANDS | NDA020325 | |
| ADVIL LIQUI-GELS | ibuprofen | HALEON US HOLDINGS | NDA020402 | |
| UNIVASC | moexipril hydrochloride | UCB INC | NDA020312 | |
| REVEX | nalmefene hydrochloride | HIKMA | NDA020459 | |
| COZAAR | losartan potassium | ORGANON | NDA020386 | |
| BETIMOL | timolol | THEA PHARMA | NDA020439 | |
| CERVIDIL | dinoprostone | FERRING PHARMS INC | NDA020411 | |
| LUPRON DEPOT | leuprolide acetate | ABBVIE ENDOCRINE INC | NDA019943 | |
| KYTRIL | granisetron hydrochloride | ROCHE | NDA020305 | |
| NASAREL | flunisolide | TEVA BRANDED PHARM | NDA020409 | |
| GLUCOPHAGE | metformin hydrochloride | EMD SERONO INC | NDA020357 | |
| LOTREL | amlodipine besylate, benazepril hydrochloride | SANDOZ | NDA020364 | |
| ULTRAM | tramadol hydrochloride | JANSSEN PHARMS | NDA020281 | |
| MEPRON | atovaquone | GLAXOSMITHKLINE LLC | NDA020500 | |
| SULAR | nisoldipine | AZURITY | NDA020356 | |
| ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | ondansetron hydrochloride | GLAXOSMITHKLINE | NDA020403 |