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