All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2005
FDA approved the original submission of 83 new drug and biologics license applications in 2005, from 67 sponsors. FDA marks 32 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER | conivaptan hydrochloride | APOTEX | NDA021697 | |
| CLIMARA PRO | estradiol, levonorgestrel | BERLEX LABS | NDA021885 | |
| REVLIMID | lenalidomide | BRISTOL MYERS SQUIBB | NDA021880 | |
| ORENCIA | abatacept | BRISTOL MYERS SQUIBB | BLA125118 | |
| ADVIL PM | diphenhydramine hydrochloride, ibuprofen | HALEON US HOLDINGS | NDA021393 | |
| ADVIL PM | diphenhydramine citrate, ibuprofen | HALEON US HOLDINGS | NDA021394 | |
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | BIOVAIL LABS INTL | NDA021763 | |
| IPLEX | mecasermin rinfabate recombinant | INSMED | BLA021884 | |
| HYLENEX RECOMBINANT | hyaluronidase recombinant human | HALOZYME THERAP | BLA021859 | |
| NEXAVAR | sorafenib tosylate | BAYER HLTHCARE | NDA021923 | |
| AVANDARYL | glimepiride, rosiglitazone maleate | SB PHARMCO | NDA021700 | |
| EXJADE | deferasirox | NOVARTIS | NDA021882 | |
| SOLTAMOX | tamoxifen citrate | MAYNE PHARMA COMMRCL | NDA021807 | |
| ARRANON | nelarabine | SANDOZ | NDA021877 | |
| KALETRA | lopinavir, ritonavir | ABBVIE | NDA021906 | |
| CLOBEX | clobetasol propionate | GALDERMA LABS LP | NDA021835 | |
| HYDASE | hyaluronidase | AKORN INC | BLA021716 | |
| LEVEMIR | insulin detemir | NOVO NORDISK | BLA021878 | |
| LORATADINE | loratadine | SUN PHARMA CANADA | NDA021734 | |
| ANGELIQ | drospirenone, estradiol | BAYER HLTHCARE | NDA021355 | |
| EMTRIVA | emtricitabine | GILEAD | NDA021896 | |
| ULTRAM ER | tramadol hydrochloride | VALEANT PHARMS | NDA021692 | |
| AMBIEN CR | zolpidem tartrate | COSETTE | NDA021774 | |
| INCRELEX | mecasermin recombinant | IPSEN INC | BLA021839 | |
| ACTOPLUS MET | metformin hydrochloride, pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA021842 | |
| FOLLISTIM AQ | follitropin alfa/beta | ORGANON USA INC | BLA021273 | |
| ALPHAGAN P | brimonidine tartrate | ABBVIE | NDA021770 | |
| FLUDEOXYGLUCOSE F18 | fludeoxyglucose f-18 | FEINSTEIN | NDA021870 | |
| NEVANAC | nepafenac | HARROW EYE | NDA021862 | |
| ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate, risedronate sodium | WARNER CHILCOTT | NDA021823 | |
| FORTICAL | calcitonin salmon recombinant | UPSHER SMITH LABS | NDA021406 | |
| QUALAQUIN | quinine sulfate | SUN PHARM INDUSTRIES | NDA021799 | |
| LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | BIONPHARMA | NDA021855 | |
| ROZEREM | ramelteon | TAKEDA PHARMS USA | NDA021782 | |
| ACZONE | dapsone | ALMIRALL | NDA021794 | |
| MEGACE ES | megestrol acetate | ENDO OPERATIONS | NDA021778 | |
| METROGEL | metronidazole | GALDERMA LABS LP | NDA021789 | |
| BIDIL | hydralazine hydrochloride, isosorbide dinitrate | AZURITY | NDA020727 | |
| SYNERA | lidocaine, tetracaine | GALEN SPECIALTY | NDA021623 | |
| APTIVUS | tipranavir | BOEHRINGER INGELHEIM | NDA021814 | |
| ALINIA | nitazoxanide | ROMARK | NDA021818 | |
| LEVEMIR FLEXTOUCH | insulin detemir recombinant | NOVO NORDISK INC | BLA021536 | |
| TYGACIL | tigecycline | PF PRISM CV | NDA021821 | |
| LYRICA | pregabalin | CP PHARMS | NDA021724 | |
| REGLAN ODT | metoclopramide hydrochloride | MEDA PHARMS | NDA021793 | |
| ZMAX | azithromycin | PF PRISM CV | NDA050797 | |
| GLUMETZA | metformin hydrochloride | SANTARUS INC | NDA021748 | |
| PREVANTICS SWABSTICK | chlorhexidine gluconate, isopropyl alcohol | PROF DSPLS | NDA021524 | |
| REVATIO | sildenafil citrate | VIATRIS | NDA021845 | |
| NAGLAZYME | galsulfase | BIOMARIN | BLA125117 | |
| FOCALIN XR | dexmethylphenidate hydrochloride | SANDOZ | NDA021802 | |
| ZEMPLAR | paricalcitol | ABBVIE | NDA021606 | |
| VANDAZOLE | metronidazole | TEVA PHARMS | NDA021806 | |
| PROQUIN XR | ciprofloxacin hydrochloride | DEPOMED INC | NDA021744 | |
| ORTHO TRI-CYCLEN 28 | ethinyl estradiol, norgestimate | ORTHO MCNEIL PHARM | NDA021690 | |
| TRIGLIDE | fenofibrate | JAGOTEC | NDA021350 | |
| DORYX MPC | doxycycline hyclate | MAYNE PHARMA | NDA050795 | |
| RYBIX ODT | tramadol hydrochloride | SHIONOGI INC | NDA021693 | |
| BYETTA | exenatide synthetic | ASTRAZENECA AB | NDA021773 | |
| CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | SAGE PRODS | NDA021669 | |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | ceftriaxone sodium | B BRAUN | NDA050796 | |
| NAMENDA | memantine hydrochloride | ALLERGAN | NDA021627 | |
| RETISERT | fluocinolone acetonide | BAUSCH AND LOMB | NDA021737 | |
| FOSAMAX PLUS D | alendronate sodium, cholecalciferol | ORGANON LLC | NDA021762 | |
| RAZADYNE ER | galantamine hydrobromide | JANSSEN PHARMS | NDA021615 | |
| CUTIVATE | fluticasone propionate | FOUGERA | NDA021152 | |
| NEXIUM IV | esomeprazole sodium | ASTRAZENECA | NDA021689 | |
| ASMANEX TWISTHALER | mometasone furoate | ORGANON LLC | NDA021067 | |
| BARACLUDE | entecavir | BRISTOL MYERS SQUIBB | NDA021797 | |
| BARACLUDE | entecavir | BRISTOL MYERS SQUIBB | NDA021798 | |
| BROMDAY | bromfenac sodium | BAUSCH AND LOMB INC | NDA021664 | |
| MYCAMINE | micafungin sodium | ASTELLAS | NDA021506 | |
| MYCAMINE | micafungin sodium | FUJISAWA HLTHCARE | NDA021754 | |
| SYMLIN | pramlintide acetate | ASTRAZENECA AB | NDA021332 | |
| XOPENEX HFA | levalbuterol tartrate | LUPIN | NDA021730 | |
| CLARINEX D 24 HOUR | desloratadine, pseudoephedrine sulfate | ORGANON | NDA021605 | |
| CARDURA XL | doxazosin mesylate | VIATRIS | NDA021269 | |
| AMMONUL | sodium benzoate, sodium phenylacetate | BAUSCH | NDA020645 | |
| VANOS | fluocinonide | BAUSCH | NDA021758 | |
| ELOXATIN | oxaliplatin | SANOFI AVENTIS US | NDA021759 | |
| NASCOBAL | cyanocobalamin | ENDO OPERATIONS | NDA021642 | |
| NIRAVAM | alprazolam | UCB INC | NDA021726 | |
| ABRAXANE | paclitaxel | BRISTOL-MYERS | NDA021660 |