The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Unichem’s Tramadol Hydrochloride tablets USP, in the strength 50 mg, Unichem Laboratories said in a regulatory filing on Tuesday.
New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator to market pain management drug Tramadol Hydrochloride tablets.
The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Unichem’s Tramadol Hydrochloride tablets USP, in the strength 50 mg, Unichem Laboratories said in a regulatory filing on Tuesday.
The approved product is a generic version of Ultram tablets, 50 mg, of Janssen Pharmaceuticals, Inc.
Tramadol Hydrochloride tablets are indicated for use in adults for the management of pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.
Unichem said the product will be commercialised from its Ghaziabad, Uttar Pradesh, plant.
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Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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