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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076280

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

Summary for 076280

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 tizanidine hydrochloride TABLET;ORAL 076280 ANDA Eon Labs, Inc. 0185-0034 0185-0034-10 1000 TABLET in 1 BOTTLE (0185-0034-10)
TIZANIDINE HYDROCHLORIDE 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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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Cantor Fitzgerald
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