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 CDER NDA Approvals for Calendar Year 2002
 Updated through December 31, 2002

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date
N021175 ATNAA Atropine; Pralidoxime Chloride US Army 3 P 17-Jan-02
N021112 TRI-LUMA Fluocinolone Acetonide; Hydroquinone; Tretinoin Hill Dermaceuticals 4 S 18-Jan-02
N021232 Orfadin Nitisinone  Swedish Orphan 1 P, O 18-Jan-02
N021343 Eligard Leuprolide Acetate ATRIX  3 S 23-Jan-02
N021360 Sustiva Efavirenz Bristol Myers Squibb 3 S 01-Feb-02
N021342 Levo-T Levothyroxine Sodium Mova  5 S 01-Mar-02
N021113 Pamidronate Disodium Pamidronate Disodium Bedford  5 S 04-Mar-02
N021299 Asimia Paroxetine Mesylate Synthon Pharms 2 S 11-Mar-02*
N021260 Avinza Morphine Sulfate Elan Pharm 3 S 20-Mar-02
N020855 Mesnex Mesna Baxter Hlthcare   3 S 21-Mar-02
N021136 SecreFlo Secretin ChiRhoClin 3 S, O 04-Apr-02
N021310 Alora Estradiol  Watson Labs 3 S 05-Apr-02
N021373 Children's Advil Cold Ibuprofen; Pseudoephedrine Hydrochloride Wyeth Consumer Healthcare 3 S 18-Apr-02
N021286 Benicar Olmesartan Medoxomil Sankyo 1 S 25-Apr-02
N021344 Faslodex Fulvestrant AstraZeneca 1 S 25-Apr-02
N021289 Bravelle Urofollitropin Ferring 3 S 06-May-02
N021272 Remodulin Treprostinil Sodium United Therapeutics 1 P, O 21-May-02
N021266 Vfend Voriconazole Pfizer 1 S 24-May-02
N021267 Vfend Voriconazole Pfizer 3 S 24-May-02
N050784 Zithromax Azithromycin Dihydrate Pfizer 3 S 24-May-02
N021374 Advil Cold/Sinus Ibuprofen; Pseudoephedrine Hydrochloride Wyeth Consumer Healthcare 3 S 30-May-02
N021191 Imagent Kit for the Preparation of Perflexane Lipid Microspheres Dimyristoylphosphatidylcholine; Perflexane Alliance Pharm 1 S 31-May-02
N021292 Novothyrox Levothyroxine Sodium Genpharm 5 S 31-May-02
N021284 Ritalin LA Methylphenidate Hydrochloride Novartis  3 S 05-Jun-02
N021212 Caverject Alprostadil Pharmacia & Upjohn 3 S 11-Jun-02
N020919 Geodon Ziprasidone Mesylate Pfizer 3 S 21-Jun-02
N021312 Clarinex  Desloratadine Schering 3 S 26-Jun-02
N021316 Altocor Lovastatin Andrx 3 S 26-Jun-02
N021282 Mucinex Guaifenesin Adams Labs 3 S 12-Jul-02
N021196 Xyrem Sodium Oxybate Orphan Medical 1 P, O 17-Jul-02
N021200 Zelnorm Tegaserod Maleate Novartis 1 P 24-Jul-02
N021379 Eligard Leuprolide Acetate Atrix 3 S 24-Jul-02
N021402 Synthroid Levothyroxine Sodium Abbott  5 S 24-Jul-02
N021409 Singulair Montelukast Sodium Merck  3 S 26-Jul-02
N021492 Eloxatin Oxaliplatin Sanofi 1 P 09-Aug-02
N021323 Lexapro Escitalopram Oxalate Forest Labs 3 S 14-Aug-02
N021241 Ortho Tri Cyclen Lo Ethinyl Estradiol; Norgestimate Johnson & Johnson 3 S 22-Aug-02
N050741 DUAC Benzoyl Peroxide; Clindamycin Phosphate Stiefel  4 S 26-Aug-02
N021447 Zanaflex Tizanidine Hydrochloride Elan Pharms 3 S 29-Aug-02
N021428 Prevacid Lansoprazole TAP Pharm 3 S 30-Aug-02
N021333 Desmopressin Acetate Desmopressin Acetate Ferring  5 S 16-Sep-02
N021425 ULTRAVIST  Iopromide Berlex Labs 3 S 20-Sep-02
N021449 HEPSERA Adefovir Dipivoxil Gilead  1 P 20-Sep-02
N050785 Augmentin XR Amoxicllin; Clavulanate Potassium GlaxoSmithKline 3 S 25-Sep-02
N021437 INSPRA Eplerenone GD Searle 1 S 27-Sep-02
N021555 Chloraprep Chlorhexidine Gluconate Beckloff  3 S 07-Oct-02
N020732 Subutex Buprenorphine Hydrochloride Reckitt Benckiser 3 S, O 08-Oct-02
N020733 Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate Reckitt Benckiser 4 P, O 08-Oct-02
N021410 Avandamet Metformin Hydrochloride; Rosiglitazone Maleate GlaxoSmithKline 4 S 10-Oct-02
N020776 Daypro Alta Oxaprozin Potassium Pharmacia 2 S 17-Oct-02
N021408 Mentax-TC Butenafine Hydrochloride Bertek 3 S 17-Oct-02
N021472 Ibuprofen Ibuprofen Banner Pharmacaps 3 S 18-Oct-02
N021460 Metaglip Glipizide; Metformin Hydrochloride Bristol Myers Squibb 4 S 21-Oct-02
N021116 Thyro-Tabs Levothyroxine Sodium Lloyd 5 S 24-Oct-02
N021445 Zetia Ezetimibe MSP Singapore 1 S 25-Oct-02
N021454 Testim Testosterone Auxilium A2 3 S 31-Oct-02
N021330 Commit  Nicotine Polacrilex GlaxoSmithKline Cons 3 S 31-Oct-02
N050763 Mytozytrex Mitomycin SuperGen 3 S 14-Nov-02
N021436 Abilify Aripiprazole Otsuka  1 S 15-Nov-02
N021498 Alinia Nitazoxanide Romark 1 P, O 22-Nov-02
N021318 Forteo Teriparatide Lilly 3 S 26-Nov-02
N021411 Strattera Atomoxetine Hydrochloride Lilly 1 S 26-Nov-02
N021365 Lexapro Escitalopram Oxalate Forest Labs 3 S 27-Nov-02
N021511 Copegus Ribavirin Roche 3 P 03-Dec-02
N050788 Mupirocin Mupirocin Clay Park 3 S 04-Dec-02
N021375 Alavert Loratadine Wyeth Consumer Healthcare 3 S 12-Dec-02*
N021473 Cipro XR Ciprofloxacin  Bayer 3 S 13-Dec-02
N021314 IDkit:Hp 13C-Urea; Citric Acid Oridion 3 S 17-Dec-02
N021419 Methylin Methylphenidate Hydrochloride Mallinckrodt 3 S 19-Dec-02
N021441 Advil Allergy Sinus Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride Wyeth Consumer Healthcare 4 S 19-Dec-02
N021484 Bravelle Urofollitropin Ferring Pharms 3 S 19-Dec-02
N020782 Depakote ER Divalproex Sodium Abbott Labs 3 S 20-Dec-02
N021321 Extraneal Icodextrin Baxter Healthcare 1 S, O 20-Dec-02
N050790 Restasis Cyclosporine Allergan 3 P 23-Dec-02*
N021470 Finacea Azelaic Acid Berlex 3 S 24-Dec-02
N021016 Relpax Eletriptan Hydrobromide Pfizer 1 S 26-Dec-02
N021478 Zovirax Acyclovir GlaxoSmithKline 3 S 30-Dec-02
N021453 Zerit XR Stavudine Bristol Myers Squibb 3 S 31-Dec-02

Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

* NDA 21299, Asimia was tentatively approved on 11-Mar-02.
* NDA 21375, Alavert was tentatively approved on 12-Dec-02 and approved on 19-Dec-02.
* NDA number for Restasis was administratively changed from 21023 to 50790.

To access approval letters, labels, and review packages, go to Drugs at FDA Logo links back to Initial Search Page

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Date created: March 5, 2004; updated January 19, 2006

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