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Reference Listed Drug Labeling Approved in October 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 |
| FLONASE |
Fluticasone propionate nasal spray |
20-121 |
S-010 |
Glaxo Wellcome |
1-Oct-1998 |
| EMCYT |
Estramustine phosphate sodium capsules |
18-045 |
S-010 |
Pharmacia and Upjohn |
9-Oct-1998 |
| COZAAR |
Losartan potassium tablets |
20-386 |
S-008 |
Merck |
13-Oct-1998 |
| VASERETIC |
Enalapril maleate and HCTZ tablets |
19-221 |
S-024 |
Merck |
13-Oct-1998 |
| TIMOLIDE |
Timolol maleate and HCTZ tablets |
18-061 |
S-025 |
Merck |
13-Oct-1998 |
| CYTOSAR-U |
Cytarabine injection |
16-793 |
S-059 |
Pharmacia and Upjohn |
15-Oct-1998 |
| NIMBEX |
Cistracurium besylate inj |
20-551 |
S-003 |
Glaxo Wellcome |
15-Oct-1998 |
| TIAZAC |
Diltiazem HCl capsule |
20-401 |
S-013 |
Bioavail Labs |
16-Oct-1998 |
| TEVETEN |
Eprosartan mesylate tablets |
20-738 |
S-001 |
SmithKline Beecham |
28-Oct-1998 |
| LINCOCIN |
Lincomycin HCl injection |
50-317 |
S-012 |
Pharmacia and Upjohn |
28-Oct-1998 |
| LINCOCIN |
Lincomycin HCl capsules |
50-316 |
S-006 |
Pharmacia and Upjohn |
28-Oct-1998 |
| PRINIZIDE |
Lisinopril and HCTZ tablets |
19-778 |
S-013 |
Merck |
28-Oct-1998 |
| NOLVADEX |
Tamoxifen citrate tablets |
17-970 |
S-040 |
Zeneca Pharmaceuticals |
29-Oct-1998 |
| NORVIR |
Ritonavir oral solution |
20-659 |
S-016 |
Abbott Labs |
30-Oct-1998 |
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Date created: August 11, 1999; last update: July 7, 2005 |
