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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 091283


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NDA 091283 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Endo Operations, Jubilant Generics, Norvium Bioscience, Novast Labs, Rubicon, Somerset Theraps Llc, Zydus Pharms, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Graviti Pharms, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in twenty-nine NDAs. It is available from fifty 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-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 091283
Tradename:TIZANIDINE HYDROCHLORIDE
Applicant:Unichem Labs Ltd
Ingredient:tizanidine hydrochloride
Patents:0
Pharmacology for NDA: 091283
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 091283
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 091283 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-168 29300-168-05 500 TABLET in 1 BOTTLE, PLASTIC (29300-168-05)
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 091283 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-168 29300-168-10 1000 TABLET in 1 BOTTLE, PLASTIC (29300-168-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 28, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Nov 28, 2012TE:ABRLD:No

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