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Reference Listed Drug Labeling Approved in May 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

Established Name

Nda No.

Supp. No.

Firm

Date

ISUPREL Isoproterenol Hydrochloride Injection

10-515

S-022

Abbott

4-May-1999

PATINOL /PLATINOL-AQ Cisplatin For Injection/Cisplatin Injection

18-057

S-068

Bristol Myers Squibb

5-May-1999

MAXAQUIN Lomefolxacin Hydrochloride

20-013

S-013

Searle

6-May-1999

URACIL MUSTARD Uracil Mustard capsules

12-892

S-001

Roberts Labs

6-May-1999

ESTROSTEP Norethindrone acetate/ethinyl estadiol tablets

20-130

S-003

Parke Davis

7-May-1999

SINEMET CR Carbidopa And Levodopa Extended-Release Tablets

19-856

S-001

Dupont

10-May-1999

PAXIL Paroxetine hydrochloride tablets

20-031

S-023

SKB Pharms

11-May-1999

FORANE Isoflurane For Inhalation

17-624

S-029

Baxter

14-May-1999

TRI-NORINYL Norethindrone And Estradiol Tablets

18-977

S-024

Searle

14-May-1999

ZOVIRAX Acyclovir Sodium For Injection

18-603

S-020

Glaxo Wellcome

19-May-1999

CLIMARA Estradiol Transdermal System

20-375

S-013

Berlex

20-May-1999

FLUDARA Fludarabine Phosphate For Injection

20-038

S-016

Berlex

24-May-1999

BAYCOL Cerivastatin tablets

20-740

S-002

Bayer

24-May-1999

STADOL Butorphanol Tartrate Injection

17-857

S-054

Apothecon

25-May-1999

XYLOCAINE Lidocaine Hydrochloride Injection

06-488

S-061

Astra

26-May-1999

CYTOXAN TABLET Cyclophosphamide Tablets

12-141

S-084

Bristol Myers Squibb

28-May-1999

CYTOXAN INJECTION Cyclophophamide Injection

12-142

S-102

Bristol Myers Squibb

28-May-1999

CYLERT TABLETS Pemoline Tablets

16-832

S-018

Abbott

28-May-1999

CYLERT CHEWABLE TABLETS Pemoline Tablets (Chewable)

17-703

S-016

Abbott

28-May-1999

PDF requires the free Adobe Acrobat Reader

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

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