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Reference Listed Drug Labeling Approved in March 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 |
| MEVACOR |
Lovastatin tablets |
19-643 |
S-057 |
Merck & Co. |
1-Mar-1999 |
| MONISTAT 3 |
Miconazole nitrate vaginal cream 4% |
20-827 |
S-001 |
Advanced Care products |
3-Mar-1999 |
ADRIMYCIN RDF
ADRIAMYCIN PFS |
Doxorubicin HCl for injection |
50-467
50-629 |
S-063
S-007 |
Pharmacia & Upjohn |
4-Mar-1999 |
| REVIA |
Naltrexone HCl tablets |
18-932 |
S-013
S-014 |
DuPont Pharmaceuticals |
5-Mar-1999 |
| REGLAN |
Metoclopramide tablets
Metoclopramide injection
Metoclopramide syrup |
17-854
17-862
18-821 |
S-039
S-042
S-018 |
Wyeth-Ayerst Laboratories |
9-Mar-1999 |
| ZOFRAN |
Ondansetron injection |
20-007
20-403 |
S-027
S-007 |
GlaxoWellcome Inc. |
10-Mar-1999 |
| PEPCID INJECTION |
Famotidine injection |
19-510
20-249 |
S-026
S-009 |
Merck Research Laboratories |
18-Mar-1999 |
PEPCID TABLETS AND SUSPENSION |
Famotidine tablets and suspension |
19-462
19-527
20-752 |
S-027
S-020
S-002 |
Merck Research Laboratories |
18-Mar-1999 |
| ALDACTONE TABLETS |
Spironolactone tablets |
12-151 |
S-060 |
Searle |
26-Mar-1999 |
| LOPRESSOR TABLETS |
Metoprolol tartrate tablets |
17-693 |
S-051 |
Novartis |
16-Mar-1999 |
| ACTIQ |
Fentanyl citrate troche/lozenge |
20-747 |
S-002 |
Anesta Corp |
26-Mar-1999 |
| EPIVIR |
Lamivudine tablets and oral solution |
20-564
20-596 |
S-007
S-007 |
Glaxo Wellcome |
23-Mar-1999 |
| XALATAN |
Latanoprost solution |
20-597 |
S-007 |
Pharmacia & Upjohn |
22-Mar-1999 |
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Date created: August 11, 1999; last update: July 7, 2005 |
