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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076533

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NDA 076533 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Jubilant Generics, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Zydus Pharms Usa Inc, Apotex, Epic Pharma Llc, 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 nineteen NDAs. It is available from forty-six 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 suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 076533

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076533

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
TABLET;ORAL 076533 ANDA Major Pharmaceuticals 0904-6418 0904-6418-61 100 BLISTER PACK in 1 CARTON (0904-6418-61) > 1 TABLET in 1 BLISTER PACK
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
TABLET;ORAL 076533 ANDA Blenheim Pharmacal, Inc. 10544-576 10544-576-02 120 TABLET in 1 BOTTLE (10544-576-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jan 16, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jan 16, 2004TE:ABRLD:No


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Fish and Richardson
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Healthtrust
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Chinese Patent Office

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