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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212053


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NDA 212053 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Aptapharma Inc, Aurobindo Pharma Ltd, Barr, Belcher, Corepharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Graviti Pharms, Havix, Mikart, Novitium Pharma, Ohm Labs, Par Pharm Inc, Pioneer Pharms, Rise Pharma, Rising, Strides Pharma, Sun Pharm Industries, Teva Pharms Usa Inc, Upsher Smith Labs, and Watson Labs, and is included in thirty-five NDAs. It is available from twenty-five 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-five suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.
Summary for 212053
Tradename:CHLORZOXAZONE
Applicant:Aptapharma Inc
Ingredient:chlorzoxazone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212053
Medical Subject Heading (MeSH) Categories for 212053
Suppliers and Packaging for NDA: 212053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORZOXAZONE chlorzoxazone TABLET;ORAL 212053 ANDA TruPharma, LLC 52817-230 52817-230-10 100 TABLET in 1 BOTTLE, PLASTIC (52817-230-10)
CHLORZOXAZONE chlorzoxazone TABLET;ORAL 212053 ANDA TruPharma, LLC 52817-231 52817-231-10 100 TABLET in 1 BOTTLE, PLASTIC (52817-231-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Sep 14, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Sep 14, 2020TE:ABRLD:No

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