All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 1991
FDA approved the original submission of 64 new drug and biologics license applications in 1991, from 48 sponsors. FDA marks 42 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| LORABID | loracarbef | KING PHARMS | NDA050667 | |
| LORABID | loracarbef | KING PHARMS | NDA050668 | |
| PENETREX | enoxacin | SANOFI AVENTIS US | NDA019616 | |
| TRIOSTAT | liothyronine sodium | PH HEALTH | NDA020105 | |
| ISMO | isosorbide mononitrate | PROMIUS PHARMA | NDA019091 | |
| ZOLOFT | sertraline hydrochloride | VIATRIS | NDA019839 | |
| CARDIZEM CD | diltiazem hydrochloride | BAUSCH | NDA020062 | |
| MACROBID | nitrofurantoin, nitrofurantoin, macrocrystalline | ALMATICA | NDA020064 | |
| RELAFEN | nabumetone | SMITHKLINE BEECHAM | NDA019583 | |
| SUPPRELIN | histrelin acetate | SHIRE | NDA019836 | |
| CEFZIL | cefprozil | CORDEN PHARMA | NDA050664 | |
| CEFZIL | cefprozil | CORDEN PHARMA | NDA050665 | |
| ZOCOR | simvastatin | ORGANON | NDA019766 | |
| ROMAZICON | flumazenil | HOFFMANN LA ROCHE | NDA020073 | |
| TORADOL | ketorolac tromethamine | ROCHE PALO | NDA019645 | |
| AMINOSYN II 10% IN PLASTIC CONTAINER | amino acids | OTSUKA ICU MEDCL | NDA020015 | |
| AMINOSYN II 15% IN PLASTIC CONTAINER | amino acids | OTSUKA ICU MEDCL | NDA020041 | |
| STADOL | butorphanol tartrate | BRISTOL MYERS SQUIBB | NDA019890 | |
| BOTOX COSMETIC | onabotulinumtoxina | ALLERGAN | BLA103000 | |
| HABITROL | nicotine | DR REDDYS LABS SA | NDA020076 | |
| METHOTREXATE SODIUM | calcium chloride, dextrose, glutathione disulfide, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate | EPIC PHARMA LLC | NDA020079 | |
| ACCUPRIL | quinapril hydrochloride | PFIZER PHARMS | NDA019885 | |
| NICODERM CQ | nicotine | CHATTEM SANOFI | NDA020165 | |
| ENLON-PLUS | atropine sulfate, edrophonium chloride | PHARMOBEDIENT | NDA019677 | |
| ENLON-PLUS | atropine sulfate, edrophonium chloride | PHARMOBEDIENT | NDA019678 | |
| ZITHROMAX | azithromycin | PFIZER | NDA050670 | |
| AREDIA | pamidronate disodium | NOVARTIS | NDA020036 | |
| BIAXIN | clarithromycin | ABBVIE | NDA050662 | |
| PRAVACHOL | pravastatin sodium | BRISTOL MYERS SQUIBB | NDA019898 | |
| TICLID | ticlopidine hydrochloride | ROCHE PALO | NDA019979 | |
| CARDIZEM | diltiazem hydrochloride | BIOVAIL LABS INTL | NDA020027 | |
| NIPENT | pentostatin | HOSPIRA INC | NDA020122 | |
| VIDEX | didanosine | BRISTOL MYERS SQUIBB | NDA020154 | |
| VIDEX | didanosine | BRISTOL MYERS SQUIBB | NDA020155 | |
| VIDEX | didanosine | BRISTOL | NDA020156 | |
| FOSCAVIR | foscarnet sodium | CLINIGEN HLTHCARE | NDA020068 | |
| DERMATOP | prednicarbate | VALEANT PHARMS NORTH | NDA019568 | |
| ORAMORPH SR | morphine sulfate | XANODYNE PHARMS INC | NDA019977 | |
| PLENDIL | felodipine | ASTRAZENECA | NDA019834 | |
| NASACORT | triamcinolone acetonide | CHATTEM SANOFI | NDA019798 | |
| DEXTROSE 60% IN PLASTIC CONTAINER | dextrose | BAXTER HLTHCARE | NDA020047 | |
| NOVOLIN N | insulin susp isophane recombinant human | NOVO NORDISK INC | BLA019959 | |
| SURVANTA | beractant | ABBVIE | BLA020032 | |
| LOTENSIN | benazepril hydrochloride | VALIDUS PHARMS | NDA019851 | |
| NOVOLIN 70/30 | insulin recombinant human, insulin susp isophane recombinant human | NOVO NORDISK INC | BLA019991 | |
| NOVOLIN R | insulin recombinant human | NOVO NORDISK INC | BLA019938 | |
| CHIBROXIN | norfloxacin | MERCK | NDA019757 | |
| ULTRATAG | technetium tc-99m red blood cell kit | CURIUM | NDA019981 | |
| SINEMET CR | carbidopa, levodopa | ORGANON LLC | NDA019856 | |
| MONOPRIL | fosinopril sodium | BRISTOL MYERS SQUIBB | NDA019915 | |
| ZOVIRAX | acyclovir | PHARMOBEDIENT | NDA020089 | |
| PROZAC | fluoxetine hydrochloride | LILLY | NDA020101 | |
| NULYTELY | polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride | AZURITY | NDA019797 | |
| FLUDARA | fludarabine phosphate | GENZYME CORP | NDA020038 | |
| VOLTAREN | diclofenac sodium | NOVARTIS | NDA020037 | |
| NUROMAX | doxacurium chloride | ABBVIE | NDA019946 | |
| LEUKINE | sargramostim | BERLEX LABS | BLA103362 | |
| TERAZOL 3 | terconazole | JANSSEN PHARMS | NDA019964 | |
| NEUPOGEN | filgrastim | AMGEN | BLA103353 | |
| LODINE | etodolac | WYETH PHARMS INC | NDA018922 | |
| CHEMET | succimer | RECORDATI RARE | NDA019998 | |
| ALTACE | ramipril | KING PHARMS LLC | NDA019901 | |
| GANITE | gallium nitrate | CHAPTER 7 TRUSTEE | NDA019961 | |
| ZOFRAN | ondansetron hydrochloride | SANDOZ | NDA020007 |