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First-Time Generics - November 2001

Approval Date Drug Name Brand Name ANDA Number Applicant
11/2/01 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG FLUMADINE TABLETS 75-916 COREPHARMA LLC
11/16/01 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, 20 MG, AND 40 MG PRILOSEC DELAYED-RELEASE CAPSULES 75-347 ANDRX PHARMACEUTICALS, INC.
11/21/01 TIOCONAZOLE VAGINAL OINTMENT 6.5% (OTC) VAGISTAT-1 VAGINAL OINTMENT 75-915 L. PERRIGO COMPANY
11/21/01 THALLOUS CHLORIDE TL-201 INJECTION, USP 1 mCi/ML THALLOUS CHLORIDE Tl-201 INJECTION, USP 75-569 MOUNT SINAI MEDICAL CENTER
11/23/01 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MG PERCOCET TABLETS 40-434 ENDO PHARMACEUTICALS, INC.
11/26/01 ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS, USP 250 MG/250 MG/65 MG, RESPECTIVELY (OTC) EXCEDRIN MIGRAINE TABLETS 75-794 L. PERRIGO COMPANY
11/29/01 PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG RYTHMOL TABLETS 75-998 MUTUAL PHARMACEUTICAL COMPANY

 

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FDA/Center for Drug Evaluation and Research
Last Updated: January 4, 2002
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