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 |
| PHENDIMETRAZINE TARTRATE CAPSULE |
Phendimetrazine Tartrate Capsule |
18-074 |
S-028 |
Eon |
3-Nov-1998 |
| BUTISOL SODIUM |
Butabarbital Sodium Tablet |
00-793 |
S-015 |
Wallace |
4-Nov-1998 |
| HYDRODIURIL |
Hydrochlorothiazide Tablet |
11-835 |
S-060 |
Merck |
5-Nov-1998 |
| ATROVENT MDI |
Ipratropium Bromide |
20-394 |
S-001 |
Boehringer-Ingelheim |
9-Nov-1998 |
| PEPCID AC |
Famotidine Tablet |
20-325 |
S-007 |
Merck |
9-Nov-1998 |
| MEZLIN |
Mezlocillin Sodium For Injection |
50-549 |
S-022 |
Bayer |
10-Nov-1998 |
| NORPACE CR |
Disopyramide Phosphate Capsule |
18-655 |
S-032 |
Searle |
10-Nov-1998 |
| NORPACE |
Disopyramide Phosphate Capsule |
17-447 |
S-054 |
Searle |
10-Nov-1998 |
| ALDOMET |
Methyldopa Tablet |
13-400 |
S-085 |
Merck |
10-Nov-1998 |
| HYDERGINE LC |
Ergoloid Mesylates Capsule |
18-706 |
S-019 |
Novartis |
12-Nov-1998 |
| HYDERGINE |
Ergoloid Mesylates Solution |
18-418 |
S-017 |
Novartis |
12-Nov-1998 |
| HYDERGINE |
Ergoloid Mesylates Tablet |
9-087 |
S-045 |
Novartis |
12-Nov-1998 |
| MYCOSTATIN PASTILLE |
Nystatin Lozenges |
50-619 |
S-002 |
Squibb |
13-Nov-1998 |
| TASMAR |
Tolcapone Tablet |
20-697 |
S-002 |
Roche |
16-Nov-1998 |
| BACTRIM |
Sulfamethoxazole and Trimethoprim Tablet |
17-377 |
S-056 |
Roche |
17-Nov-1998 |
| SERAX |
Oxazepam Capsule And Tablet |
15-539 |
S-051 |
Wyeth Ayerst |
17-Nov-1998 |
| ROCALTROL |
Calcitrol Capsule |
18-044 |
S-025 |
Roche |
20-Nov-1998 |
| VANTIN |
Cefpodoxime Proxetil Sol |
50-675 |
S-014 |
Pharmacia & Upjohn |
20-Nov-1998 |
| VANTIN |
Cefpodoxime Proxetil Tablet |
50-674 |
S-012 |
Pharmacia & Upjohn |
20-Nov-1998 |
| HISMANAL |
Astemizole Tablet |
19-402 |
S-014 |
Janssen |
23-Nov-1998 |
| COUMADIN |
Warfarin Sodium Tablet |
9-218 |
S-087 |
DuPont |
23-Nov-1998 |
| VIAGRA |
Sildenafil Citrate Tablet |
20-895 |
S-003 |
Pfizer |
24-Nov-1998 |
| EVISTA |
Raloxifene Hcl Tablet |
20-815 |
S-002 |
Lilly |
24-Nov-1998 |
| HYZAAR |
Losartan Potassium/HCTZ Tablet |
20-387 |
S-011 |
Merck |
24-Nov-1998 |
| COZAAR |
Losartan Potassium Tablet |
20-386 |
S-015 |
Merck |
24-Nov-1998 |
| XANAX |
Alprazolam Tablet |
18-276 |
S-034 |
Pharmacia & Upjohn |
24-Nov-1998 |
| DIOVAN |
Valsartan Capsule |
20-665 |
S-004 |
Novartis |
27-Nov-1998 |
| MILTOWN |
Meprobamate Tablets |
09-968 |
S-031 |
Wallace |
27-Nov-1998 |
