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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076321

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NDA 076321 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Jubilant Generics, Novast Labs, Ph Health, Pharmobedient, Rubicon Research, Zydus Pharms, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in twenty-nine NDAs. It is available from forty-nine suppliers. Additional details are available on the TIZANIDINE HYDROCHLORIDE profile page.

The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for 076321

Tradename:	TIZANIDINE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	tizanidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Sep 30, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Sep 30, 2004	TE:		RLD:	No

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