Product Name |
Established Name |
NDA No. |
Supp.No. |
Firm |
Date |
| TOPAMAX |
Topiramate Tablets |
20-505 |
S-003 |
Johnson RW |
1-Oct-1999 |
| TOPAMAX SPRINKLE |
Topiramate Capsules |
20-844 |
S-004 |
Johnson RW |
1-Oct-1999 |
| LUPRON DEPOT |
Leuprolide Acetate For Injectable Susp |
19-732 |
S-015 |
Tap Holdings |
4-Oct-1999 |
| CHEMET |
Succimer Capsules |
19-998 |
S-011 |
Sanofi Pharms |
5-Oct-1999 |
| LOVENOX |
Enoxaparin Sodium Injection |
20-164 |
S-031 |
Rhone Poulenc Rorer |
5-Oct-1999 |
| PERMAX |
Pergolide Mesylate Tablets |
19-385 |
S-026 |
Eli Lilly |
6-Oct-1999 |
| EXCEDRIN (MIGRAINE) |
Acetaminophen/Aspirin/Caffeine Tablets |
20-802 |
S-002 |
Bristol Myers |
7-Oct-1999 |
| PROZAC |
Fluoxetine HCl Capsules |
18-936 |
S-052 |
Lilly Res Labs |
7-Oct-1999 |
| PROZAC |
Fluoxetine HCl Oral Solution |
20-101 |
S-024 |
Eli Lilly |
7-Oct-1999 |
| GoLYTELY |
PEG-3350 and electrolytes for oral sol. |
19-011 |
S-013 |
Braintree Labs |
7-Oct-1999 |
| NuLYTELY |
PEG-3350,NaCl,NaHCO3,KCl for oral sol. |
19-797 |
S-011 |
Braintree Labs |
7-Oct-1999 |
| CHIBROXIN |
Norfloxacin Opthalmic Solution |
19-757 |
S-009 |
Merck |
8-Oct-1999 |
| CORDARONE |
Amiodarone HCl Tablets |
18-972 |
S-020 |
Wyeth Ayerst Labs |
8-Oct-1999 |
| XALATAN |
Latanoprost Opthalmic Sol. |
20-597 |
S-012 |
Pharmacia & Upjohn |
8-Oct-1999 |
| CIPRO HC |
Ciprofloxacin HCl/Hydrocortisone Otic Sol. |
20-805 |
S-003 |
Alcon |
14-Oct-1999 |
| PRAVACHOL |
Pravastatin Sodium Tablets |
19-898 |
S-034 |
Bristol Myers Squibb |
14-Oct-1999 |
| SANSERT |
Methysergide Maleate Tablets |
12-516 |
S-046 |
Novartis Pharms |
15-Oct-1999 |
| ULTIVA |
Remifentanil HCl |
20-630 |
S-001 |
Glaxo Wellcome |
15-Oct-1999 |
| PLEGISOL |
Cardioplegic Solution |
18-608 |
S-034 |
Abbott Labs |
18-Oct-1999 |
| EDECRIN |
Ethacrynic Acid Tablets |
16-092 |
S-037 |
Merck |
19-Oct-1999 |
| EDECRIN |
Ethacrynate Sodium Injection |
16-093 |
S-038 |
Merck |
19-Oct-1999 |
| ZAGAM |
Sparfloxacin Tablets |
20-677 |
S-002 |
Mylan Pharms |
19-Oct-1999 |
| BLENOXANE |
Bleomycin Sulfate Injection |
50-443 |
S-029 |
Bristol Myers Squibb |
20-Oct-1999 |
| NORVIR |
Ritonavir Oral Sol. |
20-659 |
S-021 |
Abbott Labs |
21-Oct-1999 |
| ZANTAC INJECTION |
Ranitidine Injection |
19-090 |
S-040 |
Glaxo Wellcome |
22-Oct-1999 |
| ZANTAC PREMIX IV |
Ranitidine /Sodium Chloride Injection |
19-593 |
S-030 |
Glaxo Wellcome |
22-Oct-1999 |
| ZANTAC SYRUP |
Ranitidine Syrup |
19-675 |
S-022 |
Glaxo Wellcome |
22-Oct-1999 |
| ZANTAC EFFERDOSE |
Ranitidine Effervescent Tablets |
20-251 |
S-008 |
Glaxo Wellcome |
22-Oct-1999 |
| ZANTAC TABLETS |
Ranitidine Tablets |
18-703 |
S-058 |
Glaxo Wellcome |
22-Oct-1999 |
| ZANTAC GELDOSE |
Ranitidine Capsules |
20-095 |
S-010 |
Glaxo Wellcome |
22-Oct-1999 |
| ESTROSTEP |
Norethindrone Acetate/Ethinyl Estradiol tablets |
20-130 |
S-005 |
Parke Davis |
25-Oct-1999 |
| TAXOL |
Paclitaxel Injection |
20-262 |
S-033 |
Bristol Myers Squibb |
25-Oct-1999 |
| VIRAMUNE |
Nevirapine Tablets |
20-636 |
S-011 |
Boehringer Pharms |
25-Oct-1999 |
| VIRAMUNE |
Nevirapine Suspension |
20-933 |
S-001 |
Boehringer Pharms |
25-Oct-1999 |
| GLYNASE |
Glyburide Tablets |
20-051 |
S-009 |
Pharmacia & Upjohn |
28-Oct-1999 |
| MICRONASE |
Glyburide Tablets |
17-498 |
S-021 |
Pharmacia & Upjohn |
28-Oct-1999 |
| NIASPAN |
Niacin Extended-Release Tablets |
20-381 |
S-006 |
KOS Pharms |
28-Oct-1999 |
| TOLINASE |
Tolazamide Tablets |
15-500 |
S-050 |
Pharmacia & Upjohn |
28-Oct-1999 |
| METHOTREXATE |
Methotrexate injection |
11-719 |
S-099 |
Lederle |
29-Oct-1999 |
| METHOTREXATE |
Methotrexate tablets |
08-085 |
S-048 |
Lederle |
29-Oct-1999 |
