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Details for New Drug Application (NDA): 040861

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NDA 040861 describes CHLORZOXAZONE, which is a drug marketed by Watson Labs, Actavis Elizabeth, Pioneer Pharms, Aurolife Pharma Llc, Mikart, Sun Pharm Inds, Par Pharm, Mikart Inc, Barr, and Ohm Labs, and is included in nineteen NDAs. It is available from nineteen suppliers. Additional details are available on the CHLORZOXAZONE profile page.

The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There are thirteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.

Summary for NDA: 040861

Therapeutic Class:Skeletal Muscle Relaxants

Pharmacology for NDA: 040861

Suppliers and Packaging for NDA: 040861

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040861 ANDA Mikart Inc. 46672-117 46672-117-10 100 TABLET in 1 BOTTLE (46672-117-10)
TABLET;ORAL 040861 ANDA Mikart Inc. 46672-117 46672-117-50 500 TABLET in 1 BOTTLE (46672-117-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Jun 1, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 1, 2010TE:RLD:Yes

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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.