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First-Time Generics - September 2006

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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

Source: US Food and Drug Administration