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Reference Listed Drug Labeling Approved in November 1999

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

Drug Name

NDA No.

Supp.No.

Firm

Date

AMINOHIPPURATE Na Na Aminohippurate

5-619

S-015

Merck

2-Nov-1999

FLOLAN Epoprostenol Na Injection

20-444

S-004

Glaxo Wellcome

2-Nov-1999

DEXEDRINE Dextroamphetamine SO4 ER Capsules

17-078

S-034

SmithKline Beecham

3-Nov-1999

ZOLADEX Goserelin Acetate Implant

20-578

S-009

Zeneca

3-Nov-1999

ZOLADEX Goserelin Acetate Implant 3.6 Mg

19-726

S-030

Zeneca

3-Nov-1999

CERVIDIL Dinoprostone Vaginal Insert

20-411

S-011

Controlled Therap

5-Nov-1999

OCUFLOX Ocuflox Ophthalmic Solution

19-921

S-008

Allergan

9-Nov-1999

ORAP Pimozide Tablets

17-473

S-033,036

Teva Pharms

9-Nov-1999

PARLODEL Bromocriptine Mesylate Tablets

17-962

S-053

Novartis Pharm

9-Nov-1999

MICRONOR Norethindrone Tablets

16-954

S-085

Johnson RW

10-Nov-1999

MERIDIA Sibutramine HCl Monohydrate Capsules

20-632

S-006

Knoll Pharm

12-Nov-1999

MEGACE Megestrol Acetate Tablets

16-979

S-048

Bristol Myers Squibb

15-Nov-1999

PARAPLATIN Carboplatin For Injection

19-880

S-010

Bristol Myers Squibb

15-Nov-1999

ORTHO CYCLEN-21 Ethinyl Estradiol/Norgestimate Tablets

19-653

S-022

Johnson RW

22-Nov-1999

ORTHO TRI-CYCLEN Ethinyl Estradiol/Norgestimate Tablets

19-697

S-018

Johnson RW

22-Nov-1999

THALLOUS Cl TL 201 Thallous Cl Injection

18-150

S-013

Mallinckrodt

22-Nov-1999

NegGram Nalidixic Acid Tablets

14-214

S-050,051

Sanofi

23-Nov-1999

NegGram Nalidixic Acid Oral Suspension

17-430

S-026,027

Sanofi

23-Nov-1999

PREGNYL Chorionic Gonadotropin For Injection

17-692

S-012

Organon

23-Nov-1999

FERTINEX Urofollitropin For Injection

19-415

S-021

Serono Labs

24-Nov-1999

LOESTRIN 21 1.5/30 Ethinyl Estradiol/Norethindrone Acetate Tablets

17-875

S-030

Parke Davis

24-Nov-1999

LOESTRIN 21 1/20 Ethinyl Estradiol/Norethindrone Acetate Tablets

17-876

S-029

Parke Davis

24-Nov-1999

LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Acetate Tablets

17-355

S-044

Parke Davis

24-Nov-1999

LOESTRIN FE 1/20 Ethinyl Estradiol/Norethindrone/Ferrous Tablets

17-354

S-042

Parke Davis

24-Nov-1999

NUTROPIN AQ Somatropin Injection

20-522

S-011

Genentech Inc

24-Nov-1999

COLY-MYCIN M Colistimethate Na Injection

50-108

S-021

Parkedale

26-Nov-1999

DIOVAN Valsartan Capsules

20-665

S-008

Novartis Pharms

29-Nov-1999

NOR-QD Norethindrone Tablets

17-060

S-064

Watson Labs

30-Nov-1999

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Last update: July 7, 2005

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