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Unichem Laboratories gets ANDA approval from USFDA for generic version of Ultram
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Unichem Laboratories gets ANDA approval from USFDA for generic version of Ultram

Agency News

Mumbai Aug 13 : Unichem Laboratories said it has received ANDA approval from US FDA for Unichem's Tramadol Hydrochloride Tablets USP, 50 mg.to market a generic version of Ultram Tablets, 50 mg, of Janssen Pharmaceuticals, Inc.

Tramadol Hydrochloride Tablets USP, 50 mg. are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The product will be commercialized from Unichem's Ghaziabad plant. (UNI)