All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2007
FDA approved the original submission of 78 new drug and biologics license applications in 2007, from 64 sponsors. FDA marks 24 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| LUVOX | fluvoxamine maleate | ANI PHARMS | NDA021519 | |
| BYSTOLIC | nebivolol hydrochloride | ALLERGAN | NDA021742 | |
| KUVAN | sapropterin dihydrochloride | BIOMARIN PHARM | NDA022181 | |
| OMEPRAZOLE | omeprazole | DEXCEL PHARMA | NDA022032 | |
| TRIESENCE | triamcinolone acetonide | HARROW EYE | NDA022048 | |
| TRIESENCE | triamcinolone acetonide | ALCON RES | NDA022223 | |
| OMNARIS | ciclesonide | NYCOMED US INC | NDA022124 | |
| CHILDREN'S ZYRTEC HIVES | cetirizine hydrochloride | KENVUE BRANDS | NDA022155 | |
| SEROQUEL XR | quetiapine fumarate | CHEPLAPHARM ARZNEIMITTEL GMBH | NDA022172 | |
| MIRCERA | methoxy polyethylene glycol-epoetin beta | HOFFMAN-LA ROCHE | BLA125164 | |
| PROTONIX | pantoprazole sodium | WYETH PHARMS | NDA022020 | |
| COMBIGAN | brimonidine tartrate, timolol maleate | ABBVIE | NDA021398 | |
| TASIGNA | nilotinib hydrochloride | NOVARTIS | NDA022068 | |
| RENVELA | sevelamer carbonate | SANOFI | NDA022127 | |
| VOLTAREN ARTHRITIS PAIN | diclofenac sodium | HALEON US HOLDINGS | NDA022122 | |
| IXEMPRA KIT | ixabepilone | R-PHARM US LLC | NDA022065 | |
| DORIBAX | doripenem | SHIONOGI | NDA022106 | |
| ISENTRESS HD | raltegravir potassium | MSD SUB MERCK | NDA022145 | |
| HYCAMTIN | topotecan hydrochloride | SANDOZ | NDA020981 | |
| SIMVASTATIN | simvastatin | SYNTHON PHARMS | NDA021961 | |
| LAMISIL | terbinafine hydrochloride | NOVARTIS | NDA022071 | |
| AMLODIPINE BESYLATE | amlodipine besylate | SYNTHON PHARMS | NDA022026 | |
| AZOR | amlodipine besylate, olmesartan medoxomil | COSETTE | NDA022100 | |
| FLUDARABINE PHOSPHATE | fludarabine phosphate | CAPLIN ONE LABS | NDA022137 | |
| EVISTA | raloxifene hydrochloride | LILLY | NDA022042 | |
| TOTECT | dexrazoxane hydrochloride | CLINIGEN | NDA022025 | |
| OMNISCAN | gadodiamide | GE HEALTHCARE | NDA022066 | |
| SOMATULINE DEPOT | lanreotide acetate | IPSEN PHARMA | NDA022074 | |
| AMMONIA N 13 | ammonia n-13 | FEINSTEIN | NDA022119 | |
| RECLAST | zoledronic acid | SANDOZ | NDA022080 | |
| ZINGO | lidocaine hydrochloride | POWDER PHARMS | NDA022114 | |
| FENOGLIDE | fenofibrate | SALIX | NDA022118 | |
| CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER | cefotetan disodium | B BRAUN | NDA065430 | |
| SELZENTRY | maraviroc | VIIV HLTHCARE | NDA022128 | |
| SANCTURA XR | trospium chloride | ALLERGAN | NDA022103 | |
| CALOMIST | cyanocobalamin | PH HEALTH | NDA022102 | |
| EVAMIST | estradiol | PADAGIS US | NDA022014 | |
| ATRALIN | tretinoin | DOW PHARM | NDA022070 | |
| CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | CHATTEM SANOFI | NDA021909 | |
| EXELON | rivastigmine | SANDOZ | NDA022083 | |
| ENDOMETRIN | progesterone | FERRING | NDA022057 | |
| EXFORGE | amlodipine besylate, valsartan | NOVARTIS | NDA021990 | |
| DIFFERIN | adapalene | GALDERMA LABS LP | NDA021753 | |
| LETAIRIS | ambrisentan | GILEAD | NDA022081 | |
| NUVIGIL | armodafinil | NUVO PHARMS | NDA021875 | |
| LEXIVA | fosamprenavir calcium | VIIV HLTHCARE | NDA022116 | |
| EXTINA | ketoconazole | RISING | NDA021738 | |
| OMACOR | omega-3acid ethyl esters | RELIANT PHARMS | NDA021853 | |
| DIVIGEL | estradiol | VERTICAL PHARMS | NDA022038 | |
| TORISEL | temsirolimus | PF PRISM CV | NDA022088 | |
| ZYFLO CR | zileuton | CHIESI | NDA022052 | |
| XYZAL | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA022064 | |
| LYBREL | ethinyl estradiol, levonorgestrel | WYETH PHARMS INC | NDA021864 | |
| LOCOID | hydrocortisone butyrate | BAUSCH | NDA022076 | |
| SEROQUEL XR | quetiapine fumarate | CHEPLAPHARM | NDA022047 | |
| LOVENOX | enoxaparin sodium | SANOFI AVENTIS US | NDA022138 | |
| PERFOROMIST | formoterol fumarate | VIATRIS SPECIALTY | NDA022007 | |
| NEUPRO | rotigotine | UCB INC | NDA021829 | |
| SUPPRELIN LA | histrelin acetate | ENDO OPERATIONS | NDA022058 | |
| AZASITE | azithromycin | THEA PHARMA | NDA050810 | |
| FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | HALEON US HOLDINGS | NDA022051 | |
| INVEGA | paliperidone | JANSSEN LP | NDA022043 | |
| TOVALT ODT | zolpidem tartrate | BIOVAIL LABS INTL | NDA021412 | |
| RECLAST | zoledronic acid | SANDOZ | NDA021817 | |
| ALTABAX | retapamulin | ALMIRALL | NDA022055 | |
| JANUMET | metformin hydrochloride, sitagliptin phosphate | MSD SUB MERCK | NDA022044 | |
| SOLIRIS | eculizumab | ALEXION PHARM | BLA125166 | |
| TYKERB | lapatinib ditosylate | NOVARTIS | NDA022059 | |
| TEKTURNA | aliskiren hemifumarate | LXO IRELAND | NDA021985 | |
| VAPRISOL | conivaptan hydrochloride | CUMBERLAND PHARMS | NDA022016 | |
| ALTACE | ramipril | KING PFIZER | NDA022021 | |
| VYVANSE | lisdexamfetamine dimesylate | TAKEDA PHARMS USA | NDA021977 | |
| ALLI | orlistat | HALEON US HOLDINGS | NDA021887 | |
| AMRIX | cyclobenzaprine hydrochloride | TEVA PHARMS INTL | NDA021777 | |
| FLECTOR | diclofenac epolamine | IBSA | NDA021234 | |
| YAZ | drospirenone, ethinyl estradiol | BAYER HLTHCARE | NDA022045 | |
| LIALDA | mesalamine | TAKEDA PHARMS USA | NDA022000 | |
| OLUX E | clobetasol propionate | QUAGEN | NDA022013 |