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Generated: April 26, 2017

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Details for New Drug Application (NDA): 076280

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NDA 076280 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Zydus Pharms Usa Inc, Apotex, Corepharma, Mylan, Apotex Inc, Par Pharm Inc, Barr, Sandoz Inc, Oxford Pharms, Actavis Elizabeth, Unichem Labs Ltd, Teva, and Dr Reddys Labs Inc, and is included in eighteen NDAs. It is available from forty-two 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-six suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 076280

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076280

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076280

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tizanidine hydrochloride
TABLET;ORAL 076280 ANDA Eon Labs, Inc. 0185-0034 0185-0034-10 1000 TABLET in 1 BOTTLE (0185-0034-10)
tizanidine hydrochloride
TABLET;ORAL 076280 ANDA Eon Labs, Inc. 0185-0034 0185-0034-51 150 TABLET in 1 BOTTLE (0185-0034-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 26, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 27, 2002TE:ABRLD:No

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