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Article: Taro Receives Final FDA Approval for Carbamazepine Extended-Release Tablets.
- Article from:
- Business Wire
- Article date:
- April 3, 2009
CopyrightCOPYRIGHT 2009 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Generic Equivalent to Novartis' Tegretol[R]-XR Tablets USP, 100 mg, 200 mg and 400 mg
HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro" or the "Company," Pink Sheets: TAROF) today reported that it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application ("ANDA") for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg ("carbamazepine extended-release tablets").
Taro's carbamazepine extended-release tablets are bioequivalent to the reference listed drug Tegretol[R]-XR Tablets of Novartis Pharmaceuticals Corporation, a prescription pharmaceutical product used for treating ...