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Reference Listed Drug Labeling Approved in July 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 |
Drug Name |
NDA No. |
Supp.No |
Firm |
Date |
| VIDEX |
Didanosine chewable tablets |
20-154 |
S-028 |
Bristol Myers Squibb |
01-Jul-1999 |
| VIDEX |
Didanosine for oral solution |
20-155 |
S-020 |
Bristol Myers Squibb |
01-Jul-1999 |
| ZERIT |
Stavudine capsules |
20-412 |
S-010 |
Bristol Myers Squibb |
01-Jul-1999 |
| ZERIT |
Stavudine oral solution |
20-413 |
S-003 |
Bristol Myers Squibb |
01-Jul-1999 |
| CAVERJECT |
Alprostadil for injection |
20-379 |
S-012 |
Pharmacia & Upjohn |
02-Jul-1999 |
| RISPERDAL |
Risperidone tablet |
20-588 |
S-005 |
Janssen |
02-Jul-1999 |
| RISPERDAL |
Risperidone |
20-272 |
S-009 |
Janssen |
02-Jul-1999 |
| PREVACID |
Lansoprazole capsule |
20-406 |
S-028 |
Tap Holdings |
06-Jul-1999 |
| PRIMACOR |
Milrinone lactate injection |
19-436 |
S-012 |
Sanofi |
06-Jul-1999 |
| PRIMACOR |
Milrinone lactate injection |
20-343 |
S-008 |
Sanofi |
06-Jul-1999 |
| TONOCARD |
Tocainide HCl tablets |
18-257 |
S-026 |
Astra Pharms |
07-Jul-1999 |
| AGGRASTAT |
Tirofiban HCl injection |
20-913 |
S-001 |
Merck |
09-Jul-1999 |
| AGGRASTAT |
Tirofiban HCl injection |
20-912 |
S-001 |
Merck |
09-Jul-1999 |
| COUMADIN |
Warfarin sodium tablets/injection |
09-218 |
S-096 |
Dupont Merck |
09-Jul-1999 |
| REGONAL |
Pyridostigmine bromide |
17-398 |
S-013 |
Organon |
12-Jul-1999 |
| OMNICEF |
Cefdinir oral suspension |
50-749 |
S-004 |
Parke Davis |
13-Jul-1999 |
| KADIAN |
Morphine sulfate extended-release capsules |
20-616 |
S-003 |
Faulding Pharm |
16-Jul-1999 |
| XALATAN |
Latanoprost opthalmic |
20-597 |
S-008 |
Pharmacia & Upjohn |
16-Jul-1999 |
| CORTISPORIN |
Neomycin and polymixin B sulfates/hydrocortisone acetate cream |
50-218 |
S-047 |
Monarch Pharms |
19-Jul-1999 |
| CORTISPORIN |
Neomycin & polymixin B sulfates/bacitracin zinc/hydrocortisone oint |
50-168 |
S-073 |
Monarch Pharms |
19-Jul-1999 |
| FLOVENT |
Fluticasone propionate |
20-549 |
S-006 |
Glaxo Wellcome |
19-Jul-1999 |
| GLUCAGON |
Glucagon for injection |
20-928 |
S-001 |
Lilly |
19-Jul-1999 |
| PENICILLIN G |
Penicillin G potassium injection |
50-638 |
S-006 |
Baxter Hlthcare |
20-Jul-1999 |
| ZITHROMAX |
Azithromycin injection |
50-733 |
S-001 |
Pfizer |
20-Jul-1999 |
| INTEGRILIN |
Intrifiban |
20-718 |
S-003 |
Cor |
21-Jul-1999 |
| TENORETIC |
Atenolol/chlorthalidone tablets |
18-760 |
S-023 |
Zeneca Pharms |
21-Jul-1999 |
| TENORMIN |
Atenolol injection |
19-058 |
S-013 |
Zeneca Pharms |
21-Jul-1999 |
| TENORMIN |
Atenolol tablets |
18-240 |
S-026 |
Zeneca Pharms |
21-Jul-1999 |
| ALDORIL |
Methyldopa/HCTZ tablets |
13-402 |
S-081 |
Merck |
23-Jul-1999 |
| TOPAMAX |
Topiramate tablets |
20-505 |
S-001 |
Johnson RW |
23-Jul-1999 |
| TOPAMAX |
Topiramate capsules |
20-844 |
S-001 |
Johnson RW |
23-Jul-1999 |
| LAMISIL |
Terbinafine emulsion gel |
20-846 |
S-001 |
Novartis Pharms |
26-Jul-1999 |
| KYTRIL |
Granisetron HCl tablets |
20-305 |
S-004 |
SKB Pharms |
27-Jul-1999 |
| TICLID |
Ticlopidine HCl |
19-979 |
S-017 |
Syntex USA |
28-Jul-1999 |
| ANCEF |
Cefazolin sodium for injection |
50-461 |
S-133 |
Smithkline Beecham |
29-Jul-1999 |
| BIAXIN |
Clarithromycin tablets |
50-662 |
S-026 |
Abbott Labs |
29-Jul-1999 |
| KEFTAB |
Cephalexin HCl tablets |
50-614 |
S-019 |
Eli Lilly |
29-Jul-1999 |
| LEVAQUIN |
Levofloxacin injection |
20-635 |
S-006 |
Johnson Rw |
29-Jul-1999 |
| LEVAQUIN |
Levofloxacin tablets |
20-634 |
S-007 |
Johnson Rw |
29-Jul-1999 |
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Date created: August 17, 1999; last update: July 7, 2005 |
