Product Name |
Established Name |
NDA No. |
Supp. No. |
Firm |
Date |
| TRUSOPT |
Dorzolamide Hcl Opth.Sol. |
20-408 |
S-013 |
Merck |
03-Aug-1998 |
| BLEPHAMIDE |
Prednisolone Acetate/Sulfacetamide Sodium Opth. Susp |
12-813 |
S-043 |
Allergan |
03-Aug-1998 |
| PROVERA |
Medroxyprogesterone Acetate Tablets |
11-839 |
S-068 |
Pharmacia And Upjohn |
04-Aug-1998 |
| OVCON-35 |
Ethinyl Estradiol/Norethindrone Tablets |
18-127 |
S-033 |
Bristol-Myers Squibb |
10-Aug-1998 |
| OVCON-35 |
Ethinyl Estradiol/Norethindrone Tablets |
17-716 |
S-045 |
Bristol-Myers Squibb |
10-Aug-1998 |
| OVCON-35 |
Ethinyl Estradiol/Norethindrone Tablets |
17-756 |
S-045 |
Bristol-Myers Squibb |
10-Aug-1998 |
| GYNE-LOTRIMIN 7-DAY |
Clotrimazole Vaginal Cream (OTC) |
18-052 |
S-025 |
Schering-Plough |
11-Aug-1998 |
| DEPO-PROVERA |
Medroxyprogesterone Acetate Injection |
20-246 |
S-012 |
Pharmacia Upjohn |
12-Aug-1998 |
| VIAGRA |
Sildenafil Citrate Tablets |
20-895 |
S-002 |
Pfizer |
13-Aug-1998 |
| TRANDATE (letter only) |
Labetalol Hcl Injection |
19-425 |
S-019 |
Glaxo Wellcome |
13-Aug-1998 |
| TRANDATE (letter only) |
Labetalol Hcl Tablets |
18-716 |
S-022 |
Glaxo Wellcome |
13-Aug-1998 |
| PROPULSID QUICKSOLV |
Cisapride Monohydrate Tablets |
20-767 |
S-005 |
Jansssen |
17-Aug-1998 |
| ACCOLATE |
Zafirlukast Tablets |
20-547 |
S-006 |
Zeneca |
17-Aug-1998 |
| PROPULSID |
Cisapride Monohydrate Suspension |
20-398 |
S-015 |
Janssen |
17-Aug-1998 |
| PROPULSID |
Cisapride Monohydrate Tablets |
20-210 |
S-026 |
Janssen |
17-Aug-1998 |
| PRAVACHOL |
Pravastatin Sodium Tablets |
19-898 |
S-021 |
Bristol-Myers Squibb |
17-Aug-1998 |
| DDAVP |
Desmopressin Acetate Injection |
18-938 |
S-013 |
Rhone-Poulenc Rorer |
17-Aug-1998 |
| ARICEPT |
Donepezil Hcl Tablets |
20-690 |
S-005 |
Eisai |
18-Aug-1998 |
| MARPLAN |
Isocarboxazid Tablets |
11-961 |
S-017 |
Roche |
18-Aug-1998 |
| CLOZARIL |
Clozapine Tablets |
19-758 |
S-036 |
Novartis |
19-Aug-1998 |
| MODURETIC 5-50 |
Amiloride Hcl/HCTZ Tablets |
18-201 |
S-034 |
Merck |
24-Aug-1998 |
| LAMICTAL |
Lamotrigene Tablets |
20-241 |
S-002 |
Glaxo Wellcome |
24-Aug-1998 |
| HYZAAR |
HCTZ/Losartan Potassium Tablets |
20-387 |
S-010 |
Merck |
25-Aug-1998 |
| GEMZAR |
Gemcitabine Hcl Inj |
20-509 |
S-005 |
Lilly |
25-Aug-1998 |
| LIPITOR |
Atovastan Calcium Tablets |
20-702 |
S-014 |
Warner Lambert |
28-Aug-1998 |
| MEVACOR |
Lovastatin Tablets |
19-643 |
S-056 |
Merck |
28-Aug-1998 |
| TRASYLOL |
Aprotinin Bovine Inj |
20-304 |
S-004 |
Bayer |
28-Aug-1998 |
| HIVID |
Zalcitabine Tablets |
20-199 |
S-011 |
Roche |
29-Aug-1998 |
| AVAPRO HCT |
Hydrochlorothiazide/Irbesartan Tablets |
20-758 |
S-003 |
Bristol-Myers Squibb |
31-Aug-1998 |
| COZAAR |
Losartan Potassium Tablets |
20-386 |
S-014 |
Merck |
31-Aug-1998 |