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Reference Listed Drug Labeling Approved in July 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 |
| QUINAGLUTE DURA-TABS |
Quinidine gluconate ER tablets |
16-647 |
S-035 |
Berlex |
1-July-1998 |
| CARDIOQUIN |
Quinidine polygalacturonate tablets |
11-642 |
S-011 |
Purdue Frederick |
1-July-1998 |
| LIPITOR |
Atorvastatin calcium tablet |
20-702 |
S-003 |
Warner Lambert Export Ltd |
10-July-1998 |
| ORTHO-NOVUM 1/50 28 |
Mestranol/norethindrone tablets |
16-709 |
S-123 |
RW Johnson |
10-July-1998 |
| ORTHO-NOVUM 1/50 21 |
Mestranol/norethindrone tablets |
12-728 |
S-188 |
RW Johnson |
10-July-1998 |
| AVAPRO HCT |
Irbesartan/HCTZ tablets |
20-758 |
S-007 |
Sanofi |
14-July-1998 |
| PLENDIL |
Felodipine ER tablets |
19-834 |
S-013 |
Astra Merck |
14-July-1998 |
| VERELAN |
Verapamil HCl ER tablets |
19-614 |
S-024 |
Lederle |
14-July-1998 |
| TICLID |
Ticlopidine HCl tablets |
19-979 |
S-015 |
Syntex |
15-July-1998 |
| LANOXICAPS |
Digoxin capsules |
18-118 |
S-016 |
Glaxo Wellcome |
15-July-1998 |
| LANOXIN |
Digoxin injection |
9-330 |
S-020 |
Glaxo Wellcome |
15-July-1998 |
| PREVACID |
Lansprazole delayed-release capsule |
20-406 |
S-021 |
Tap Holdings |
20-July-1998 |
| BIAXIN |
Clarithromycin tablets |
50-662 |
S-022 |
Abbott |
21-July-1998 |
| DYNABAC |
Dirithromycin tablet |
50-678 |
S-005 |
Eli Lilly |
22-July-1998 |
| LEXXEL |
Enalapril maleate/felodipine tablets |
20-668 |
S-004 |
Astra Merck |
22-July-1998 |
| ZOLADEX |
Goserelin acetate implant |
20-578 |
S-003 |
Zeneca LTD |
27-July-1998 |
| COREG |
Carvedilol tablets |
20-297 |
S-003 |
SmithKline Beecham |
28-July-1998 |
| LOTENSIN HCT |
Benazepril HCl and HCTZ tablets |
20-033 |
S-013 |
Novartis |
29-July-1998 |
| LOTENSIN |
Benazepril HCl tablets |
19-851 |
S-016 |
Novartis |
29-July-1998 |
| DOBUTREX |
Dobutamine injection |
17-820 |
S-036 |
Eli Lilly |
29-July-1998 |
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Date created: August 11, 1999; last update: July 7, 2005 |
