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Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 215158

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NDA 215158 describes CHLORZOXAZONE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Glenmark Pharms Ltd, I3 Pharms, Mayne Pharma, Mikart, Novitium Pharma, Ohm Labs, Par Pharm, Par Pharm Inc, Pioneer Pharms, Rising, Senores Pharms, Sun Pharm Industries, Teva Pharms Usa Inc, and Watson Labs, and is included in twenty-seven NDAs. It is available from twenty-three suppliers. Additional details are available on the CHLORZOXAZONE profile page.

The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There are sixteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
Summary for 215158
Applicant:Senores Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 215158
Medical Subject Heading (MeSH) Categories for 215158
Suppliers and Packaging for NDA: 215158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORZOXAZONE chlorzoxazone TABLET;ORAL 215158 ANDA Cintex Services, LLC 24470-923 24470-923-10 100 TABLET in 1 BOTTLE (24470-923-10)
CHLORZOXAZONE chlorzoxazone TABLET;ORAL 215158 ANDA Cintex Services, LLC 24470-923 24470-923-60 60 TABLET in 1 BOTTLE (24470-923-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 29, 2021TE:AARLD:No

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