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Details for New Drug Application (NDA): 078868

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NDA 078868 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: 078868

Tradename:
TIZANIDINE HYDROCHLORIDE
Applicant:
Apotex Inc
Ingredient:
tizanidine hydrochloride
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078868

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 078868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
CAPSULE;ORAL 078868 ANDA AvKARE, Inc. 42291-810 42291-810-15 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-810-15)
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
CAPSULE;ORAL 078868 ANDA AvKARE, Inc. 42291-811 42291-811-15 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 6MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No


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