Division of Drug Information Service
Available for Purchase: FDA Drug Approval Packages



Individual FDA Approval Packages are available for U.S. $400.00 on
CD-ROM or via email, in Adobe Acrobat® PDF format.


The contents provided in most FDA Approval Packages include: Approval Letter(s), Labeling,
Administrative Documents, Medical Review(s), Statistical Review(s), Clinical Pharmacology and
Biopharmaceutics Review(s), Pharmacology Review(s), Microbiology Review(s), Chemistry
Reviews, Correspondence and Memoranda.

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GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Abacavir ZiagenTM 20-977
20-978		 12/17/1998
Abarelix PlenaxisTM 21320
 11/25/2003
Acamprosate Calcium Campral® 21431
 7/29/2004
Acarbose* Precose® 20-482
 9/6/1995
Acrivastine/Pseudoephedrine HCl* Semprex-D® 19-806
 3/25/1994
Adalimumab HumiraTM 125057
 12/31/2002
Adefovir Dipivoxil HepseraTM 21-449
 9/20/2002
Agalsidase beta Fabrazyme® 103979/
 4/24/2003
Alatrofloxacin Mesylate* TrovanTM 20-760
20-759		 12/18/1997
Albendazole* AlbenzaTM 20-666
 6/11/1996
Alefacept Ameviva® 1204
 1/30/2003
Alemtuzumab* Campath® 103948/
 5/7/2001
Alendronate* Fosamax® 20-560
 9/29/1995
Alfuzosin UroxatralTM 21-287
 6/12/2003
Alitretinoin 0.1% Panretin® 20-886
 2/2/1999
Almotriptan Malate AxertTM 21-001
 5/7/2001
Alosetron Hydrochloride LotronexTM 21-107
 2/9/2000
Amifostine* Ethyol® 20-221
 12/8/1995
Aminolevulinic Acid HCl Levulan KerastickTM 20-965
 12/3/1999
Amlexanox AphthasolTM 20-511
 12/17/1996
Anagrelide HCl* Agrylin® 20-333
 3/14/1997
Anastrozole* Arimidex® 20-541
 12/27/1995
Anti-thymocyte globulin, rabbit Thymoglobulin® #384
 12/30/1998
Aprepitant Emend® 21549
 3/26/2003
Arcitumomab* Cea-Scan® 91-0209
 6/28/1996
Ardeparin Sodium* Normiflo® 20-227
 5/23/1997
Argatroban AcovaTM 20-883
 6/30/2000
Aripiprazole AbilifyTM 21-436
 11/15/2002
Arsenic trioxide TrisenoxTM 21-248
 9/25/2000
Atomoxetine StratteraTM 21-411
 11/26/2002
Atorvastatin Calcium* Lipitor® 20-702
 12/17/1996
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Azelaic Acid* AzelexTM 20-428
 9/13/1995
Azelastine* Astelin® 20-114
 11/1/1996
Balsalazide Disodium ColazalTM 20-610
 7/18/2000
Basiliximab Simulect® 97-1251
 5/12/1998
Becaplermin, Platelet Derived Growth Factor Regranex® 96-1408
 12/16/1997
Bentoquatam Ivy Block 5% LotionTM 20-532
 8/26/1996
Betaine, Anhydrous Cystadane® 20-576
 10/25/1996
Bevacizumab AvastinTM 1250850
 2/26/2004
Bexarotene Targretin® 21-055
 12/29/1999
Bicalutimide* Casodex® 20-498
 10/4/1995
Bimatoprost LumiganTM 21-275
 3/16/2001
Bivalirudin AngiomaxTM 20-873
 12/15/2000
Bleomycin Sulfate (Sterile)* Blenoxane® 50-443
 2/20/1996
Bortezomib VelcadeTM 21-602
 5/13/2003
Bosentan TracleerTM 21-290
 11/20/2001
Brimonidine* Alphagan® 20-613
 9/6/1996
Brinzolamide AzoptTM 20-816
 4/1/1998
Bromfenac Sodium* DuractTM 20-535
 7/15/1997
Budesonide* Rhinocort® 20-233
 2/14/1994
Butenafine MentaxTM 20-524
 10/18/1996
Cabergoline* Dostinex® 20-664
 12/23/1996
Calcitonin-Salmon Miacalcin® 20-313
 8/17/1995
Calfactant Infasurf® 20-521
 7/1/1998
Candesartan Cilexetil Atacand® 20-838
 6/4/1998
Capecitabine XelodaTM 20-896
 4/30/1998
Caspofungin Acetate Cancidas® 21-227
 1/29/2001
Cefditoren pivoxil SpectracefTM 21-222
 8/29/2001
Cefepime* Maxipime® 50-679
 1/18/1996
Ceftibuten Dihydrate* Cedax® 50-685
 12/20/1995
Celecoxib Celebrex® 20-998
 12/31/1998
Cerivastatin Sodium* BaycolTM 20-740
 6/26/1997
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Cetirizine Hydrochloride* Zyrtec® 19-835
 12/12/1995
Cetrorelix Acetate CetrotideTM 21-297
 8/11/2000
Cetuximab ErbituxTM 1250840
 2/12/2004
Cevimeline HCl EvoxacTM 20-989
 1/11/2000
Cidofovir* Vistide® 20-638
 6/26/1996
Cilostazol Pletal® 20-863
 1/15/1999
Cisatracurium* NimbexTM 50-551
 12/15/1995
Citalopram CelexaTM 20-882
 7/17/1998
Clofarabine ClolarTM 21673
 12/28/2004
Clopidogrel Bisulfate* Plavix® 20-839
 11/17/1997
Colesevelam WelcholTM 21-141
 5/26/2000
Corticorelin Ovine Triflutate* Acthrel® 20-162
 5/23/1996
Cysteamine Bitartrate* Cystagon® 20-392
 8/15/1994
Daclizumab* Zenapax® 97-0736
 12/10/1997
Dalfopristin and Quinupristin Synercid® 50-748
 9/21/1999
Dalteparin Sodium* Fragmin® 20-287
 12/22/1994
Danaparoid Sodium* Orgaran® 20-430
 12/24/1996
Deferasirox Exjade® 021882
 11/2/2005
Delavirdine* Rescriptor® 20-705
 4/4/1997
Denileukin diftitox Ontak® 1258
 2/5/1999
Desloratadine Clarinex® 21-297
21-165		 2/8/2002
Desloratadine Clarinex® 21-165
21-297		 12/21/2001
Desmopressin* DDAVP® 19-955
 9/6/1995
Dexmedetomidine HCl PrecedexTM 21-038
 12/17/1999
Dexrazoxane* Zinecard® 20-212
 5/26/1995
Digoxin Immune Fab (Ovine)* DigiFabTM 1545
 8/31/2001
Dirithromycin* Dynabac® 50-678
 6/19/1995
Docetaxel* Taxotere® 20-449
 5/14/1996
Docosanol AbrevaTM 20-841
 7/25/2000
Dofetilide TikosynTM 20-931
 10/1/1999
Dolasetron Mesylate* Anzemet® 20-623
 9/11/1997
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Dorzolamide HCl* Trusopt® 20-408
 12/9/1994
Doxercalciferol HectorolTM 20-862
 6/9/1999
Duloxetine Hydrochloride Cymbalta® 21427
 8/3/2004
Dutasteride DuagenTM 21-319
 11/20/2001
Efavirenz SustivaTM 20-972
 9/17/1998
Eletriptan Hydrobromide RelpaxTM 21-016
 12/26/2002
Emtricitabine EmtrivaTM 21-500
 7/2/2003
Entacapone Comtan® 20-796
 10/19/1999
Entecavir BaracludeTM 21797
21798		 3/29/2005
Epinastine hydrochloride ElestatTM 21-565
 10/16/2003
Epirubicin EllenceTM 50-778
 9/15/1999
Eplerenone InspraTM 21-437
 9/27/2002
Epoprostenol Sodium* Flolan® 20-444
 9/20/1995
Eptifibatide IntegrilinTM 20-718
 5/18/1998
Eszopiclone LunestaTM 21476
 12/15/2004
Etanercept EnbrelTM 98-0286
 11/2/1998
Ethinyl Estradiol/Etonogestrel Nuvaring® 21-287
 10/3/2001
Exemestane Aromasin® 20-753
 10/21/1999
Exenatide synthetic ByettaTM 021773
 4/28/2005
Ezetimibe ZetiaTM 21-445
 10/25/2002
Famciclovir* Famvir® 20-363
 6/29/1994
Fenofibrate* Lipidil® 19-304
 12/31/1993
Fenoldopam Mesylate* Corlopam® 19-922
 9/23/1997
Ferumoxides* Feridex® 20-416
 8/30/1996
Fexofenadine HCl* Allegra® 20-625
 7/25/1996
Fibrin Sealant Tisseel VH Kit® 87-0508
 5/1/1998
Fludeoxyglucose, F 18* Fludeoxygl® 20-306
 8/19/1994
Flunisolide* NasarelTM 20-409
 3/8/1995
Fluvoxamine Maleate* Luvox® 20-243
 12/5/1994
Fomepizole* Antizol® 20-696
 12/4/1997
Fomivirsen sodium VitraveneTM 20-961
 8/26/1998
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Fondaparinux Sodium ArixtraTM 21-345
 12/7/2001
Formoterol Fumarate Foradil Aerolizer® 21-831
 2/16/2001
Fosfomycin Tromethamine* Monurol® 50-717
 12/19/1996
Fosphenytoin Sodium* Cerebyx® 20-450
 8/5/1996
Frovatriptan FrovaTM 21-006
 11/8/2001
Fulvestrant Faslodex® 21344
 4/25/2002
Gadoversetamide OptiMARK® 20-976
20-937 20-975		 12/8/1999
Galantamine Hydrobromide Reminyl® 21-169
 2/28/2001
Ganirelix AntagonTM 21-057
 7/29/1999
Gatifloxacin* TequinTM 21-061
21-062		 12/17/1999
Gatifloxacin* TequinTM 21-062
21-061		 12/17/1999
Gefitinib IressaTM 21-399
 5/5/2003
Gemcitabine* Gemzar® 20-509
 5/15/1996
Gemtuzumab Ozogomicin MylotargTM 21-174
 5/17/2000
Grepafloxacin HCl* RaxarTM 20-695
 11/6/1997
Hepatitis A Vaccine, Inactivated* Havrix® 1090
 2/22/1995
Ibandronate sodium BonivaTM 21-455
 5/16/2003
Icodextrin ExtranealTM 21-321
 12/20/2002
Imatinib GleevecTM 21-335
 5/10/2001
Imiglucerase* Cerezyme® 20-367
 5/23/1994
Imiquimod* Aldara® 20-723
 2/27/1997
Indium 111 Pentetreotide* Octreoscan® 20-314
 6/2/1994
Infliximab RemicadeTM 98-0012
 8/24/1998
Insulin Detemir LevemirTM 021536
 6/16/2005
Insulin glulisine ApidraTM 21629
 4/16/2004
Interferon Alfacon-1* Infergen® 96-0486
 10/6/1997
Interferon Beta-1A* Avonex® 95-0979
 5/17/1996
Iodixanol* VisipaqueTM 20-351
 3/22/1996
Iopromide* Ultravist® 20-220
 5/10/1995
Irbesartan* Avapro® 20-757
 9/30/1997
Irinotecan Hydrochloride* Camptosar® 20-571
 6/14/1996
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Itraconazole* Sporanox® 20-083
 9/11/1992
Ketotifen Fumarate ZaditorTM 21-066
 7/2/1999
Lamotrigine* Lamictal® 20-241
 12/27/1994
Lansoprazole* Prevacid® 20-406
 5/10/1995
Latanoprost* Xalatan® 20-597
 6/5/1996
Leflunomide AravaTM 20-905
 9/10/1998
Lenalidomide Revlimid® 021880
 12/27/2005
Lepirudin RefludanTM 20-807
 3/6/1998
Letrozole* Femara® 20-726
 7/25/1997
Levetiracetam KeppraTM 21-035
 11/30/1999
Lidocaine 2% / Epinephrine 1:100,00* IontocaineTM 20-530
 12/21/1995
Losartan* Cozaar® 20-386
 4/14/1995
Losartan/HCTZ* Hyzaar® 20-387
 4/28/1995
Loteprednol Etabonate LotemaxTM 20-841
 3/9/1998
Loteprednol Etabonate LotemaxTM 20-583
 3/9/1998
Lyme Disease Vaccine (Recombinant OspA) LYMErixTM 97-1052
 12/21/1998
M-Iodobenzyl Guanidine Sulfate, I-1* Iobenguane Sulf® 20-084
 3/25/1994
Mangafodipir Trisodium* TeslascanTM 20-652
 11/26/1997
Mecasermin IncrelexTM 021839
 8/30/2005
Meloxicam Mobic® 20-938
 4/13/2000
Memantine hydrochloride NamendaTM 21-487
 10/16/2003
Metformin* Glucophage® 20-357
 12/29/1994
Mibefradil Dihydrochloride Posicor® 20-689
 6/20/1997
Midodrine* Proamatine® 19-815
 9/6/1996
Mifepristone MifeprexTM 20-687
 9/28/2000
Miglitol* Glyset® 20-682
 12/18/1996
Miglustat Zavesca® 21-348
 7/31/2003
Mirtazapine* Remeron® 20-415
 7/14/1996
Modafinil ProvigilTM 20-717
 12/24/1998
Moexipril* Univasc® 20-312
 4/19/1995
Moxifloxacin Hydrochloride AveloxTM 21-085
 12/10/1999
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Mupirocin calcium* Bactroban Nasal® 50-703
 9/18/1995
Mycophenolate Mofetil* Cellcept® 50-722
 5/3/1995
Nalmefene* RevexTM 20-459
 4/17/1995
Naratriptan HCl AmergeTM 20-763
 2/10/1998
Natalizumab Tysabri® 125104
 11/23/2004
Nefazodone* Serzone® 20-152
 12/22/1994
Nelfinavir Mesylate Viracept® 20-778
20-779		 3/14/1997
Nesiritide Citrate Natrecor® 20-920
 8/10/2001
Nevirapine Viramune® 20-636
 6/21/1996
Nilutamide* NilandronTM 20-169
 9/19/1996
Nitazoxanide AliniaTM 21-498
 11/22/2002
Nitisinone Orfadin® 21-232
 1/18/2002
Nitric Oxide INOmaxTM 20-845
 12/23/1999
Olanzapine* Zyprexa® 20-592
 9/30/1996
Olmesartan Medoxomil BenicarTM 21-286
 4/25/2002
Omalizumab Xolair® 1048
 6/20/2003
Oprelvekin, Recombinant Interleukin 11* Neumega® 96-1433
 11/25/1997
Orlistat Xenical® 20-766
 4/23/1999
Oseltamivir Phosphate TamifluTM 21-087
 10/27/1999
Ovine hyaluronidase Vitrase® 21640
 5/5/2004
Oxaliplatin EloxatinTM 21-492
 8/9/2002
Oxcarbazepine TrileptalTM 21-014
 1/14/2000
Palivizumab SynagisTM 97-1359
 6/19/1998
Palonosetron hydrochloride AloxiTM 21-372
 7/25/2003
Pantoprazole Sodium Protonix 20-987
 2/2/2000
Paricalcitol Zemplar® 20-819
 4/17/1998
Pegaptanib Macugen® 21756
 12/17/2004
Pegvisomant Somervert® 21106
 3/25/2003
Pemetrexed disodium Alimta® 21462
 2/4/2004
Pemirolast potassium AlamastTM 21-079
 9/24/1999
Penciclovir* Denavir® 20-629
 9/24/1996
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Pentosan Polysulfate Sodium* Elmiron® 20-193
 9/26/1996
Perflutren Lipid Microspheres DefinityTM 21-064
 7/31/2001
Pimecrolimus ElidelTM 21-302
 12/13/2001
Pioglitazone ActosTM 21-073
 7/15/1999
Polyvalent crotalide antivenom, ovine Fab* CroFabTM 103988
 10/2/2000
Poractant Alfa Curosurf® 20-744
 11/18/1999
Pramipexole Dihydrochloride* Mirapex® 20-667
 7/1/1997
Prussian blue RadiogardaseTM 21-626
 10/2/2003
Rabeprazole sodium AciphexTM 20-973
 8/19/1999
Ramelteon RozeremTM 021782
 7/22/2005
Rapacuronium Bromide RaplonTM 20-984
 8/18/1999
Rasburicase ElitekTM 1294
 7/12/2002
Remifentanil HCl* UltivaTM 20-630
 7/12/1996
Repaglinide* PrandinTM 20-741
 12/22/1997
Rifapentine Priftin® 21-024
 6/22/1998
Riluzole* Rilutek® 20-599
 12/12/1995
Rimexolone* Vexol® 20-474
 12/30/1994
Risedronate Actonel® 20-835
 3/27/1998
Ritonavir* Norvir® 20-659
 3/1/1996
Rituximab* Rituxan® 97-0244
 11/26/1997
Rivastigmine Exelon® 20-823
 4/21/2000
Rizatriptan Benzoate Maxalt® 20-864
 6/29/1998
Rocuronium Bromide* Zemuron® 20-214
 3/17/1994
Rofecoxib Vioxx® 21-042
21-052		 5/20/1999
Ropinirole HCl* Requip® 20-658
 9/19/1997
Ropivacine HCl* Naropin® 20-533
 9/24/1996
Rosiglitazone AvandiaTM 21-071
 5/25/1999
Rotavirus Vaccine RotaShield® 71-0111
 8/31/1998
Sacrosidase SucraidTM 20-772
 4/9/1998
Salmeterol* Serevent® 20-236
 2/4/1994
Samarium Sm 153 EDTMP* Quadramet® 20-570
 3/28/1997
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Saquinavir Mesylate* Invirase® 20-628
 12/6/1995
Sertaconazole nitrate ErtaczoTM 21385
 12/10/2003
Sevelamer Hydrochloride RenaGel® 20-926
 10/30/1998
Sevoflurane* Ultane® 20-478
 6/7/1995
Sildenafil Citrate Viagra® 20-895
 3/27/1998
Sirolimus Rapamune® 21-083
 9/15/1999
Sodium Ferric Gluconate Ferrlecit® 20-955
 2/18/1999
Sodium Phenylbutyrate* Buphenyl® 20-572
 5/13/1996
Somatropin* Bio-Tropin® 19-774
 5/25/1995
Sorafenib Nexavar® 021923
 12/20/2005
Sparfloxacin* Zagam® 20-677
 12/19/1996
Spirapril* Renormax® 20-240
 12/30/1994
Stavudine* Zerit® 20-412
 6/24/1994
Tacrolimus* Prograf® 50-708
 4/8/1994
Tadalafil Cialis® 21368
 11/21/2003
Tamsulosin HCl* Flomax® 20-579
 4/15/1997
Tazarotene* Tazorac® 20-600
 6/13/1997
Technetium 99M Tetrofosmin* MyoviewTM 20-372
 2/9/1996
Technetium Tc 99M Depreotide NeoTectTM 21-012
 8/3/1999
Technetium TC-99m Apcitide AcuTectTM 20-887
 9/14/1998
Tegaserod maleate ZelnormTM 21-200
 7/24/2002
Telmisartan Micardis® 20-850
 11/10/1998
Temozolomide TemodarTM 21-029
 8/11/1999
Thalidomide ThalomidTM 20-785
 7/16/1998
Thyrotropin alpha Thyrogen® 20-898
 11/30/1998
Tiagabine HCl* Gabitril® 20-646
 9/30/1997
Tiludronate Disodium* Skelid® 20-707
 3/7/1997
Tinzaparin Sodium InnohepTM 20-484
 7/14/2000
Tirofiban Aggrastat® 20-912
20-913		 5/14/1998
Tizanidine HCl* Zanaflex® 20-397
 11/27/1996
Tolcapone TasmarTM 20-697
 1/29/1998
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Tolterodine Tartrate DetrolTM 20-771
 3/25/1998
Topiramate* Topamax® 20-505
 12/24/1996
Topotecan* Hycamtin® 20-671
 5/28/1996
Toremifene Citrate Fareston® 20-497
 5/29/1997
Tramadol* Ultram® 20-281
 3/3/1995
Trandolapril* Mavik® 20-528
 4/26/1996
Trastuzumab Herceptin® 98-0369
 9/25/1998
Travoprost TravatanTM 21-257
 3/16/2001
Treprostinil RemodulinTM 21-272
 5/21/2002
Tretinoin Emollient Cream* Renova® 19-963
 12/29/1995
Trovafloxacin Mesylate* TrovanTM 20-759
20-760		 12/18/1997
Unoprostone isopropyl Rescula® 21-214
 8/3/2000
Urea, C-13* UBT Breath TestTM 20-586
 9/17/1996
Urea, C-14* Pytest® 20-617
 5/9/1997
Valacyclovir* Valtrex® 20-487
 6/23/1995
Valdecoxib BextraTM 21-341
 11/16/2001
Valrubicin ValstarTM 20-892
 9/25/1998
Valsartan* Diovan® 20-665
 12/23/1996
Verteporfin VisudyneTM 21-119
 4/12/2000
Vinorelbine Tartrate* Navelbine® 20-388
 12/23/1994
Zafirlukast* Accolate® 20-547
 9/26/1996
Zaleplon SonataTM 20-859
 8/13/1999
Zanamivir RelenzaTM 21-036
 7/26/1999
Zoledronic acid Zometa® 21-223
 8/20/2001
Zolmitriptan ZomigTM 20-768
 11/25/1997
Zonisamide ZonegranTM 20-789
 3/27/2000

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College of Pharmacy

© Copyright The University of Iowa 2006. All rights reserved.                      6/20/2007