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 |
| VEPESID |
Etoposide Capsule
Etoposide Injection |
19-557
18-768 |
S-023
S-041 |
Bristol |
2-Apr-1999 |
| NOLVADEX |
Tamoxifen Citrate Tablet |
17-970 |
S-043 |
Zeneca Pharms |
2-Apr-1999 |
| ZOLADEX 3-MONTH |
Goserelin Acetate Implant |
20-578 |
S-001 |
Zeneca Pharms |
14-Apr-1999 |
| CHILDREN'S MOTRIN ORAL SUSPENSION 40 MG/ML |
Ibuprofen Oral Suspension (Concentrated - Drops) |
20-603 |
S-003 |
Mc Neil |
15-Apr-1999 |
| GABITRIL |
Tiagabine Hcl Tablet |
20-646 |
S-005 |
Abbott |
16-Apr-1999 |
| STADOL NS |
Butorphanol Tartrate Nasal Spray |
19-890 |
S-014 |
Bristol Myers Squibb |
16-Apr-1999 |
| BRETYLIUN TOSYLATE IN DEXTROSE 5% IN FLEXIBLE CONTAINER |
Bretylium Tosylate/Dextrose Injection |
19-008 |
S-019 |
Abbott |
16-Apr-1999 |
| AVALIDE |
Irbesartan/Hctz Tablet |
20-758 |
S-011 |
Sanofi |
20-Apr-1999 |
| LOVENOX |
Enoxaprin Sodium Injection |
20-164 |
S-021 |
Rhone Poulenc Rorer |
20-Apr-1999 |
| ADENOCARD |
Adenosine Injection |
19-937 |
S-015 |
Fujisawa |
20-Apr-1999 |
| CAPOTEN |
Captopril Tablets |
18-343 |
S-073 |
Bristol Myers Squibb |
20-Apr-1999 |
| DOBUTAMINE HCL IN DEXTROSE 5% IN PLASTIC CONTAINER |
Dobutamine/Dextrose Injection |
20-255 |
S-005 |
Baxter Healthcare |
21-Apr-1999 |
| NITROGLYCERIN IN DEXTROSE 5% |
Nitroglycerin/Dextrose Injection |
19-970 |
S-010 |
Baxter Healthcare |
21-Apr-1999 |
| ALDACTAZIDE |
Spironolactone/Hctz Tablet |
12-616 |
S-062 |
Searle Pharm. |
21-Apr-1999 |
| BACTROBAN |
Mupiricin Ointment |
50-591 |
S-022 |
Smithkline Beecham |
22-Apr-1999 |
| CARBOCAINE |
Mepivacaine Hcl Injection |
12-250 |
S-019 |
Sterling Winthrop |
27-Apr-1999 |
| TOBRADEX |
Tobramycin/Dexamthasone Ophthalmic Ointment |
50-616 |
S-011 |
Alcon |
28-Apr-1999 |
| NORVIR |
Ritonavir Capsules |
20-680 |
S-012 |
Abbott |
29-Apr-1999 |
| DIPRIVAN |
Propofol Injectable Emulsion |
19-627 |
S-012 |
Abbott |
29-Apr-1999 |
| OVIDE |
Malathion Lotion |
18-613 |
S-010 |
Medicis Pharm. |
30-Apr-1999 |
