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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
Novartis
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Colorcon
Express Scripts
Medtronic
Julphar
Johnson and Johnson
Dow

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091502

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NDA 091502 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-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 091502

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

Pharmacology for NDA: 091502

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 091502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
CAPSULE;ORAL 091502 ANDA Mylan Pharmaceuticals Inc. 0378-1665 0378-1665-19 150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1665-19)
TIZANIDINE HYDROCHLORIDE
tizanidine hydrochloride
CAPSULE;ORAL 091502 ANDA Mylan Pharmaceuticals Inc. 0378-1666 0378-1666-19 150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1666-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Nov 9, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Nov 9, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 6MG BASE
Approval Date:Nov 9, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Daiichi Sankyo
Citi
Fish and Richardson
Federal Trade Commission
Chubb
Teva
Queensland Health
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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