Unichem Labs wins USFDA nod for pain management drug Tramadol Hydrochloride tablets

Published On 2019-08-13 04:30 GMT   |   Update On 2019-08-13 04:30 GMT

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.


Also Read: Unichem Labs gets tentative USFDA nod for a generic version of JnJ Zyrtec-D 12 Hour

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.


Also Read: Unichem Labs Ghaziabad facility successfully completes USFDA inspection
Article Source : PTI

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News