FDA approves Unichem’s generic Ultram

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FDA approves Unichem’s generic Ultram

By Sandra Levy - 08/20/2019
Unichem Laboratories has received the Food and Drug Adminstration’s nod for tramadol hydrochloride tablets in a dosage strength of 50 mg.

The product is the generic of Janssen’s Ultram tablets, 50 mg.

It is 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.

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