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Reference Listed Drug Labeling Approved in January 2000

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 PDF Doc format.

TRADENAME

ACTIVE/DOSAGE FORM

NDA/SUPP#

FIRM

JAN

ESTRING Estradiol/vaginal insert

20-472/S-003

Pharmacia & Upjohn

3

PREMPHASE Conj. estrogens & medroxyprogesterone/tab

20-527/S-015

Wyeth Ayerst

6

PREMPRO Conj. estrogens & medroxyprogesterone/tab

20-527/S-015

Wyeth Ayerst

6

MUTAMYCINPDF Doc Mitomycin/inj

62-336/S-024

Bristol Myers

6

DOVONEX Calcipotriene/topical sol

20-611/S-005

Westwood Squibb

11

AGGRASTAT Tirofiban HCl/inj

20-912/S-004

Merck Res

11

PERCOCETPDF Doc Oxycodone/APAP/tab

40-341/S-004

Endo Pharms

11

DROXIA Hydroxyurea/cap

16-295/S-033

Bristol Myers Squibb

12

HYDREAPDF Doc Hydroxyurea/cap

16-295/S-033

Bristol Myers Squibb

12

INFANTS' ADVIL Ibuprofen/oral susp

20-812/S-003

Whitehall Robin

12

PRAVACHOL Pravastatin Na+/tab

19-898/S-030

Bristol Myers Squibb

18

BREVIBLOC Esmolol HCl/inj

19-386/S-016

Baxter Pharm

19

MONOKETPDF Doc Isosorbide mononitrate/tab

20-215/S-011

Schwarz Pharma

19

SULAR Nisoldipine/tab

20-356/S-008

Zeneca

19

COZAAR Losartan K+/tab

20-386/S-020

Merck

19

HYZAAR Losartan K+ & HCTZ/tab

20-387/S-017

Merck

19

ORTHO-NOVUM PDF Doc Norethindrone & ethinyl estradiol/tab

18-354/S-038

Johnson RW

21

COMBIVIR Lamivudine & zidovudine/tab

20-857/S-006

Glaxo Wellcome

21

VIAGRA Sildenafil citrate/tab

20-895/S-005

Pfizer, Inc.

21

COSOPT Dorzolamide HCl & timolol maleate/opth. sol. 20-869/S-003 Merck 23
TRI-NORINYLPDF Doc Norethindrone & ethinyl estradiol/tab 18-977/S-027 Watson 24
ALOPRIM Allopurinol Na+/inj 20-298/S-001 Catalytica 28
COZAAR Losartan K+/tab

20-386/S-020

Merck 28
EMLA Lidocaine & Prilocaine/cream 19-941/S-011 AstraZeneca 28
HYZAAR Losartan K+ & HCTZ/tab

20-387/S-014

Merck

28

INOCORPDF Doc Amirinone lactate/inj 18-700/S-019 Sanofi 28

FDA/Center for Drug Evaluation and Research
Last Updated: October 02, 2001
Originator: OTCOM/DML
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