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Reference Listed Drug Labeling Approved in June 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 |
| COUMADIN |
Warfarin sodium tablets and injection |
9-218 |
S-090 |
DuPont Merck |
1-Jun-1998 |
| ZOVIRAX |
Acyclovir injection |
18-603 |
S019 |
Glaxo Wellcome |
2-Jun-1998 |
| CAPOZIDE |
Captopril/HCTZ tablets |
18-709 |
S-030 |
ER Squibb |
3-Jun-1998 |
| CHILDREN'S MOTRIN |
Ibuprofen suspension |
20-516 |
S-002 |
McNeil |
4-Jun-1998 |
| CEDAX |
Ceftibuten dihydrate |
50-686 |
S-007 |
Schering Plough |
15-Jun-1998 |
| QUINIDINE GLUCONATE |
Quinidine gluconate injection |
7-529 |
S-016 |
Eli Lilly |
15-Jun-1998 |
| FEMPATCH |
Estradiol transdermal system |
20-417 |
S-002 |
Parke Davis |
17-Jun-1998 |
| DELESTROGEN |
Estradiol valerate injection |
9-402 |
S-036 |
ER Squibb |
17-Jun-1998 |
| RENESE |
Polythiazide tablets |
12-845 |
S-026 |
Pfizer |
24-Jun-1998 |
| QUINIDEX |
Quinidine sulfate extended-release tablets |
12-796 |
S-048 |
Wyeth Ayerst |
24-Jun-1998 |
| ZOCOR |
Simvastatin tablets |
19-766 |
S-029 |
Merck |
29-Jun-1998 |
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Date created: August 11, 1999; last update: July 7, 2005 |
