Details for New Drug Application (NDA): 040792

NDA 040792 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Allied, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Hikma Intl Pharms, Natco, Nostrum Labs Inc, Novast Labs, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Wanbang Biopharms, Watson Labs, Watson Labs Teva, Genus, and Ingenus Pharms Nj, and is included in thirty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the CARISOPRODOL profile page.

The generic ingredient in CARISOPRODOL is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.

Summary for 040792

Tradename:	CARISOPRODOL
Applicant:	Aurobindo Pharma
Ingredient:	carisoprodol
Patents:	0

Pharmacology for NDA: 040792

Physiological Effect

Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 040792

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 040792

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARISOPRODOL	carisoprodol	TABLET;ORAL	040792	ANDA	Rising Pharma Holdings, Inc.	16571-780	16571-780-01	100 TABLET in 1 BOTTLE (16571-780-01)
CARISOPRODOL	carisoprodol	TABLET;ORAL	040792	ANDA	Rising Pharma Holdings, Inc.	16571-781	16571-781-01	100 TABLET in 1 BOTTLE (16571-781-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	350MG
Approval Date:	Aug 6, 2009	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 8, 2016	TE:	AB	RLD:	No

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