All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 1998
FDA approved the original submission of 102 new drug and biologics license applications in 1998, from 75 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 |
|---|---|---|---|---|
| CELEBREX | celecoxib | UPJOHN | NDA020998 | |
| PROVIGIL | modafinil | NUVO PHARMS | NDA020717 | |
| CHILDREN'S ADVIL | ibuprofen | HALEON US HOLDINGS | NDA020944 | |
| TROVAN/ZITHROMAX COMPLIANCE PAK | azithromycin dihydrate, trovafloxacin mesylate | PFIZER | NDA050762 | |
| ZIAGEN | abacavir sulfate | VIIV HLTHCARE | NDA020977 | |
| ZIAGEN | abacavir sulfate | VIIV HLTHCARE | NDA020978 | |
| DITROPAN XL | oxybutynin chloride | JANSSEN PHARMS | NDA020897 | |
| PROMETRIUM | progesterone | VIRTUS PHARMS | NDA020843 | |
| EPIVIR-HBV | lamivudine | GLAXOSMITHKLINE | NDA021003 | |
| EPIVIR-HBV | lamivudine | GLAXOSMITHKLINE | NDA021004 | |
| THYROGEN | thyrotropin alfa | GENZYME | BLA020898 | |
| SANDOSTATIN LAR | octreotide acetate | NOVARTIS | NDA021008 | |
| VERELAN PM | verapamil hydrochloride | AZURITY | NDA020943 | |
| GYNE-LOTRIMIN 3 | clotrimazole | BAYER HEALTHCARE LLC | NDA020574 | |
| METROLOTION | metronidazole | GALDERMA LABS LP | NDA020901 | |
| ROCALTROL | calcitriol | ESJAY PHARMA | NDA021068 | |
| ACTIVELLA | estradiol, norethindrone acetate | AMNEAL | NDA020907 | |
| MICARDIS | telmisartan | BOEHRINGER INGELHEIM | NDA020850 | |
| ACTIQ | fentanyl citrate | CEPHALON | NDA020747 | |
| ENBREL | etanercept | IMMUNEX | BLA103795 | |
| RENAGEL | sevelamer hydrochloride | GENZYME | NDA020926 | |
| SONORX | simethicone-cellulose | BRACCO | NDA020773 | |
| ROXICODONE | oxycodone hydrochloride | ROXANE | NDA020932 | |
| TOPAMAX SPRINKLE | topiramate | JANSSEN PHARMS | NDA020844 | |
| TIMOLOL MALEATE | timolol maleate | SANDOZ | NDA020963 | |
| VERSED | midazolam hydrochloride | ROCHE | NDA020942 | |
| NEURONTIN | gabapentin | VIATRIS | NDA020882 | |
| PAXIL | paroxetine hydrochloride | APOTEX | NDA020885 | |
| CELLCEPT | mycophenolate mofetil | ROCHE PALO | NDA050759 | |
| PERIOSTAT | doxycycline hyclate | COLLAGENEX | NDA050744 | |
| HERCEPTIN | trastuzumab | GENENTECH | BLA103792 | |
| VALSTAR PRESERVATIVE FREE | valrubicin | ENDO OPERATIONS | NDA020892 | |
| PEPCID AC | famotidine | KENVUE BRANDS | NDA020801 | |
| AREDIA | pamidronate disodium | NOVARTIS | NDA020927 | |
| SUSTIVA | efavirenz | BRISTOL MYERS SQUIBB | NDA020972 | |
| ACUTECT | technetium tc-99m apcitide | CIS BIO INTL SA | NDA020887 | |
| GLUCAGON | glucagon | LILLY | NDA020928 | |
| VIRAMUNE | nevirapine | BOEHRINGER INGELHEIM | NDA020933 | |
| ARAVA | leflunomide | SANOFI AVENTIS US | NDA020905 | |
| ATRIDOX | doxycycline hyclate | DEN-MAT | NDA050751 | |
| PREVEN EMERGENCY CONTRACEPTIVE KIT | ethinyl estradiol, levonorgestrel | TEVA BRANDED PHARM | NDA020946 | |
| PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | amino acids | BAXTER HLTHCARE | NDA020849 | |
| VITRAVENE PRESERVATIVE FREE | fomivirsen sodium | NOVARTIS | NDA020961 | |
| LAMICTAL CD | lamotrigine | GLAXOSMITHKLINE LLC | NDA020764 | |
| REMICADE | infliximab | CENTOCOR INC | BLA103772 | |
| CELLCEPT | mycophenolate mofetil hydrochloride | ROCHE PALO | NDA050758 | |
| COMBIPATCH | estradiol, norethindrone acetate | NOVEN PHARMS INC | NDA020870 | |
| ESCLIM | estradiol | WOMEN FIRST HLTHCARE | NDA020847 | |
| CELEXA | citalopram hydrobromide | ABBVIE | NDA020822 | |
| THALOMID | thalidomide | BRISTOL-MYERS | NDA020785 | |
| LEVLITE | ethinyl estradiol, levonorgestrel | BAYER HLTHCARE | NDA020860 | |
| AMOXIL | amoxicillin | US ANTIBIOTICS | NDA050754 | |
| INFASURF PRESERVATIVE FREE | calfactant | ONY | BLA020521 | |
| MAXALT | rizatriptan benzoate | ORGANON LLC | NDA020864 | |
| MAXALT-MLT | rizatriptan benzoate | ORGANON | NDA020865 | |
| GLUCAGEN | glucagon hydrochloride | NOVO NORDISK | NDA020918 | |
| PRIFTIN | rifapentine | SANOFI AVENTIS US | NDA021024 | |
| SYNAGIS | palivizumab | SWEDISH ORPHAN | BLA103770 | |
| SULFAMYLON | mafenide acetate | MYLAN INSTITUTIONAL | NDA019832 | |
| ATACAND | candesartan cilexetil | ANI PHARMS | NDA020838 | |
| REBETOL | ribavirin | MERCK SHARP DOHME | NDA020903 | |
| OPTIRAY 300 | ioversol | LIEBEL-FLARSHEIM | NDA020923 | |
| PEPCID RPD | famotidine | MERCK | NDA020752 | |
| INTEGRILIN | eptifibatide | MSD SUB MERCK | NDA020718 | |
| PERIOCHIP | chlorhexidine gluconate | DEXCEL PHARMA | NDA020774 | |
| AGGRASTAT | tirofiban hydrochloride | MEDICURE | NDA020912 | |
| AGGRASTAT | tirofiban hydrochloride | MEDICURE | NDA020913 | |
| PROMETRIUM | progesterone | ACERTIS PHARMS | NDA019781 | |
| SIMULECT | basiliximab | NOVARTIS | BLA103764 | |
| STERANE | prednisolone acetate | PFIZER | NDA011446 | |
| RETAVASE | reteplase | EKR THERAP | BLA103786 | |
| DICLOFENAC SODIUM | diclofenac sodium | FALCON PHARMS | NDA020809 | |
| XELODA | capecitabine | CHEPLAPHARM | NDA020896 | |
| LAMISIL | terbinafine | KARO HLTHCARE | NDA020846 | |
| MIRCETTE | desogestrel, ethinyl estradiol | TEVA BRANDED PHARM | NDA020713 | |
| ZEMPLAR | paricalcitol | ABBVIE | NDA020819 | |
| SUCRAID | sacrosidase | QOL MEDCL | BLA020772 | |
| COSOPT | dorzolamide hydrochloride, timolol maleate | THEA PHARMA | NDA020869 | |
| AZOPT | brinzolamide | SANDOZ | NDA020816 | |
| CILOXAN | ciprofloxacin hydrochloride | SANDOZ | NDA020369 | |
| MONISTAT 3 | miconazole nitrate | MEDTECH PRODUCTS | NDA020827 | |
| ACTONEL | risedronate sodium | APIL | NDA020835 | |
| VIAGRA | sildenafil citrate | VIATRIS | NDA020895 | |
| DETROL | tolterodine tartrate | UPJOHN | NDA020771 | |
| ALREX | loteprednol etabonate | BAUSCH AND LOMB | NDA020803 | |
| LOTEMAX | loteprednol etabonate | BAUSCH AND LOMB | NDA020583 | |
| LOTEMAX | loteprednol etabonate | PHARMOS | NDA020841 | |
| DIOVAN HCT | hydrochlorothiazide, valsartan | NOVARTIS | NDA020818 | |
| ETOPOPHOS PRESERVATIVE FREE | etoposide phosphate | BRISTOL MYERS SQUIBB | NDA020906 | |
| ZANTAC 75 | ranitidine hydrochloride | CHATTEM SANOFI | NDA020745 | |
| ZOSYN IN PLASTIC CONTAINER | piperacillin sodium, tazobactam sodium | BAXTER HLTHCARE CORP | NDA050750 | |
| SINGULAIR | montelukast sodium | ORGANON | NDA020829 | |
| SINGULAIR | montelukast sodium | ORGANON | NDA020830 | |
| AMERGE | naratriptan hydrochloride | GLAXOSMITHKLINE LLC | NDA020763 | |
| CIPRO HC | ciprofloxacin hydrochloride, hydrocortisone | SANDOZ | NDA020805 | |
| EMLA | lidocaine, prilocaine | ASTRAZENECA | NDA020962 | |
| DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | HIKMA | NDA050731 | |
| INFANT'S ADVIL | ibuprofen | HALEON US HOLDINGS | NDA020812 | |
| AVITA | tretinoin | RISING | NDA020400 | |
| TASMAR | tolcapone | BAUSCH | NDA020697 | |
| EXCEDRIN (MIGRAINE RELIEF) | acetaminophen, aspirin, caffeine | HALEON US HOLDINGS | NDA020802 | |
| LIPOSYN III 30% | soybean oil | HOSPIRA | NDA020181 |