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Article: U.S. FDA approves new drug application for generic topical cortisone ointment.
- Article from:
- Immunotherapy Weekly
- Article date:
- September 1, 2004
CopyrightCOPYRIGHT 2004 NewsRX. 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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2004 SEP 1 - (NewsRx.com & NewsRx.net) -- Taro Pharmaceutical Industries Ltd. (TARO) reported that its U.S. affiliate has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Alclometasone Dipropionate Ointment, USP 0.05% (alclometasone ointment).
Taro's alclometasone ointment is bioequivalent to GlaxoSmithKline's Aclovate ointment, a low- to medium-potency topical corticosteroid product. Alclometasone ointment, a prescription ...