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TIZANIDINE HYDROCHLORIDE

ANDA

TIZANIDINE HYDROCHLORIDE | A076281 | OXFORD PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZANAFLEX(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Acorda Therapeutics, Inc. FDA-2007-P-0189 Acorda Therapeutics, Inc. filed this petition requesting that the FDA incorporate the full proprietary name "Zanaflex Capsules" in the Orange Book instead of the truncated form "Zanaflex" under NDA 21-447, arguing that the current listing creates patient safety risks by causing prescription substitu	Other	2008-05-08	Withdrawn	Acorda Therapeutics

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain7 active DMFs4 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDTIZANIDINE HYDROCHLORIDE USP

DMF 156992001

SUN PHARMACEUTICAL INDUSTRIES LTDTIZANIDINE HYDROCHLORIDE USP

DMF 157272001

TAPI NL BVTIZANIDINE HYDROCHLORIDE USP

DMF 158202002

MATRIX PHARMACORP PRIVATE LTDTIZANIDINE HYDROCHLORIDE USP

DMF 223542008

SYMED LABS LTDTIZANIDINE HYDROCHLORIDE USP

DMF 339002019

ZYDUS LIFESCIENCES LTDTIZANIDINE HYDROCHLORIDE USP

DMF 349292020

DR REDDYS LABORATORIES LTDTIZANIDINE HYDROCHLORIDE USP (TZN-PROCESS)

DMF 414312025

SANDOZ PHARMA LTDInactiveTIZANIDINE HYDROCHLORIDE

DMF 92421991

FARCHEMIA SRLInactiveTIZANIDINE HYDROCHLORIDE

DMF 155552001

HETERO DRUGS LTDInactiveTIZANIDINE HYDROCHLORIDE

DMF 157302001

APOTEX PHARMACHEM INDIA PVT LTDInactiveTIZANIDINE HYDROCHLORIDE USP

DMF 222822008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — EQ 2MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 20, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 20, 2003