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Details for New Drug Application (NDA): 091283

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NDA 091283 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Apotex, Corepharma, Mylan, Apotex Inc, Barr, Sandoz Inc, Oxford Pharms, Actavis Elizabeth, Unichem Labs Ltd, Teva, and Dr Reddys Labs Inc, and is included in fifteen NDAs. It is available from forty 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. Forty-four suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 091283

Tradename:
TIZANIDINE HYDROCHLORIDE
Applicant:
Unichem Labs Ltd
Ingredient:
tizanidine hydrochloride
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

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 NCS HealthCare of KY, Inc dba Vangard Labs 0615-7996 0615-7996-39 30 TABLET in 1 BLISTER PACK (0615-7996-39)
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)

Summary for product number 001

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

Summary for product number 002

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


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