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Available for Purchase: FDA Drug Approval Packages



Individual FDA Approval Packages are available for 630.00 USD
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 20-978
20-977
12/17/1998
Abacavir ZiagenTM 20-977
20-978
12/17/1998
Acarbose* Precose® 20-482
9/6/1995
Acrivastine/Pseudoephedrine HCl* Semprex-D® 19-806
3/25/1994
Alatrofloxacin Mesylate* TrovanTM 20-760
20-759
12/18/1997
Albendazole* AlbenzaTM 20-666
6/11/1996
Alemtuzumab* Campath® 103948/
5/7/2001
Alendronate Fosamax® 20-560
9/29/1995
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
Arcitumomab* Cea-Scan® 91-0209
6/28/1996
Ardeparin Sodium* Normiflo® 20-227
5/23/1997
Argatroban AcovaTM 20-883
6/30/2000
Arsenic trioxide TrisenoxTM 21-248
9/25/2000
Atorvastatin Calcium Lipitor® 20-702
12/17/1996
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
Bexarotene Targretin® 21-055
12/29/1999
Bicalutimide* Casodex® 20-498
10/4/1995
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Bimatoprost LumiganTM 21-275
3/16/2001
Bivalirudin AngiomaxTM 20-873
12/15/2000
Bleomycin Sulfate (Sterile)* Blenoxane® 50-443
2/20/1996
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
Cetirizine Hydrochloride* Zyrtec® 19-835
12/12/1995
Cetrorelix Acetate CetrotideTM 21-297
8/11/2000
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
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
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
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
Delavirdine* Rescriptor® 20-705
4/4/1997
Denileukin diftitox Ontak® 1258
2/5/1999
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
Dorzolamide HCl* Trusopt® 20-408
12/9/1994
Doxercalciferol HectorolTM 20-862
6/9/1999
Dutasteride DuagenTM 21-319
11/20/2001
Efavirenz SustivaTM 20-972
9/17/1998
Entacapone Comtan® 20-796
10/19/1999
Epirubicin EllenceTM 50-778
9/15/1999
Epoprostenol Sodium Flolan® 20-444
9/20/1995
Eptifibatide IntegrilinTM 20-718
5/18/1998
Etanercept EnbrelTM 98-0286
11/2/1998
Ethinyl Estradiol/Etonogestrel Nuvaring® 21-287
10/3/2001
Exemestane Aromasin® 20-753
10/21/1999
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
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
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
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
Gadoversetamide OptiMARK® 20-937
20-975 20-976
12/8/1999
Gadoversetamide OptiMARK® 20-976
20-937 20-975
12/8/1999
Gadoversetamide OptiMARK® 20-975
20-937 20-976
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
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
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
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
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Iopromide* Ultravist® 20-220
5/10/1995
Irbesartan* Avapro® 20-757
9/30/1997
Irinotecan Hydrochloride* Camptosar® 20-571
6/14/1996
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
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 20-583
3/9/1998
Loteprednol Etabonate LotemaxTM 20-841
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
Meloxicam Mobic® 20-938
4/13/2000
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
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
Mupirocin calcium Bactroban Nasal® 50-703
9/18/1995
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
Mycophenolate Mofetil* Cellcept® 50-722
5/3/1995
Nalmefene RevexTM 20-459
4/17/1995
Naratriptan HCl AmergeTM 20-763
2/10/1998
Nefazodone* Serzone® 20-152
12/22/1994
Nelfinavir Mesylate Viracept® 20-779
20-778
3/14/1997
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
Nitric Oxide INOmaxTM 20-845
12/23/1999
Olanzapine Zyprexa® 20-592
9/30/1996
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
Oxcarbazepine TrileptalTM 21-014
1/14/2000
Palivizumab SynagisTM 97-1359
6/19/1998
Pantoprazole Sodium Protonix 20-987
2/2/2000
Paricalcitol Zemplar® 20-819
4/17/1998
Pemirolast potassium AlamastTM 21-079
9/24/1999
Penciclovir* Denavir® 20-629
9/24/1996
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
Rabeprazole sodium AciphexTM 20-973
8/19/1999
Rapacuronium Bromide RaplonTM 20-984
8/18/1999
Remifentanil HCl* UltivaTM 20-630
7/12/1996
Repaglinide* PrandinTM 20-741
12/22/1997
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
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
Saquinavir Mesylate* Invirase® 20-628
12/6/1995
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
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
Tamsulosin HCl* Flomax® 20-579
4/15/1997
Tazarotene* Tazorac® 20-600
6/13/1997
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
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
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
Tirofiban Aggrastat® 20-913
20-912
5/14/1998
Tizanidine HCl* Zanaflex® 20-397
11/27/1996
Tolcapone TasmarTM 20-697
1/29/1998
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
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
GENERIC NAME
BRAND NAME
NDA NO.
APPROVAL DATE
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

       *These documents have not been formatted for distribution and require additional preparation time before they are available.

College of Pharmacy

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