- Source : Press Release
- Date : 2019-08-13
- Event type : Approved
- Companies : Unichem Laboratories Ltd.
Unichem Laboratories Receives USFDA ANDA Approval for Tramadol Hydrochloride Tablets
Unichem Laboratories 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. which 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.