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Reference Listed Drug Labeling Approved in August 1998

Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.  Click on the product name to view the approved labeling changes in Adobe Acrobat format.

Product Name

Established Name

NDA No.

Supp. No.

Firm

Date

TRUSOPT Dorzolamide Hcl Opth.Sol.

20-408

S-013

Merck

03-Aug-1998

BLEPHAMIDE Prednisolone Acetate/Sulfacetamide Sodium Opth. Susp

12-813

S-043

Allergan

03-Aug-1998

PROVERA Medroxyprogesterone Acetate Tablets

11-839

S-068

Pharmacia And Upjohn

04-Aug-1998

OVCON-35 Ethinyl Estradiol/Norethindrone Tablets

18-127

S-033

Bristol-Myers Squibb

10-Aug-1998

OVCON-35 Ethinyl Estradiol/Norethindrone Tablets

17-716

S-045

Bristol-Myers Squibb

10-Aug-1998

OVCON-35 Ethinyl Estradiol/Norethindrone Tablets

17-756

S-045

Bristol-Myers Squibb

10-Aug-1998

GYNE-LOTRIMIN 7-DAY Clotrimazole Vaginal Cream (OTC)

18-052

S-025

Schering-Plough

11-Aug-1998

DEPO-PROVERA Medroxyprogesterone Acetate Injection

20-246

S-012

Pharmacia Upjohn

12-Aug-1998

VIAGRA Sildenafil Citrate Tablets

20-895

S-002

Pfizer

13-Aug-1998

TRANDATE (letter only) Labetalol Hcl Injection

19-425

S-019

Glaxo Wellcome

13-Aug-1998

TRANDATE (letter only) Labetalol Hcl Tablets

18-716

S-022

Glaxo Wellcome

13-Aug-1998

PROPULSID QUICKSOLV Cisapride Monohydrate Tablets

20-767

S-005

Jansssen

17-Aug-1998

ACCOLATE Zafirlukast Tablets

20-547

S-006

Zeneca

17-Aug-1998

PROPULSID Cisapride Monohydrate Suspension

20-398

S-015

Janssen

17-Aug-1998

PROPULSID Cisapride Monohydrate Tablets

20-210

S-026

Janssen

17-Aug-1998

PRAVACHOL Pravastatin Sodium Tablets

19-898

S-021

Bristol-Myers Squibb

17-Aug-1998

DDAVP Desmopressin Acetate Injection

18-938

S-013

Rhone-Poulenc Rorer

17-Aug-1998

ARICEPT Donepezil Hcl Tablets

20-690

S-005

Eisai

18-Aug-1998

MARPLAN Isocarboxazid Tablets

11-961

S-017

Roche

18-Aug-1998

CLOZARIL Clozapine Tablets

19-758

S-036

Novartis

19-Aug-1998

MODURETIC 5-50 Amiloride Hcl/HCTZ Tablets

18-201

S-034

Merck

24-Aug-1998

LAMICTAL Lamotrigene Tablets

20-241

S-002

Glaxo Wellcome

24-Aug-1998

HYZAAR HCTZ/Losartan Potassium Tablets

20-387

S-010

Merck

25-Aug-1998

GEMZAR Gemcitabine Hcl Inj

20-509

S-005

Lilly

25-Aug-1998

LIPITOR Atovastan Calcium Tablets

20-702

S-014

Warner Lambert

28-Aug-1998

MEVACOR Lovastatin Tablets

19-643

S-056

Merck

28-Aug-1998

TRASYLOL Aprotinin Bovine Inj

20-304

S-004

Bayer

28-Aug-1998

HIVID Zalcitabine Tablets

20-199

S-011

Roche

29-Aug-1998

AVAPRO HCT Hydrochlorothiazide/Irbesartan Tablets

20-758

S-003

Bristol-Myers Squibb

31-Aug-1998

COZAAR Losartan Potassium Tablets

20-386

S-014

Merck

31-Aug-1998

PDF requires the free Adobe Acrobat Reader

Date created: August 11, 1999; last update: July 7, 2005

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