October 7, 2006 - 1:09pm
First-Time Generic Approvals - September 2006
Tablets/Capsules Only
| Generic Drug Name |
Generic Manufacturer |
Referenced Brand Name |
Approval Date |
|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG (BASE) | WATSON LABORATORIES | SEASONALE TABLETS, 0.15 MG/0.03 MG | 09-06-06 |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, (OTC) 2 MG/125 MG | RANBAXY LABORATORIES | IMODIUM ADVANCED CAPLETS (OTC) | 09-06-06 |
| TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG | MYLAN PHARMACEUTICALS | TOPAMAX TABLETS | 09-11-06 |
| DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, (ONCE-A-DAY DOSAGE) 420 MG | K V PHARMACEUTICAL | TIAZAC EXTENDED-RELEASE CAPSULES | 09-12-06 |
| FAMOTIDINE TABLETS USP, (OTC) 20 MG | DR REDDY'S LABORATORIES | PEPCID AC TABLETS 20 MG | 09-25-06 |
| FAMOTIDINE TABLETS USP, (OTC) 20 MG | PERRIGO | PEPCID AC TABLETS 20 MG | 09-25-06 |