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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 205126


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NDA 205126 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Fosun Wanbang, Heritage, Hikma Intl Pharms, Mpp Pharma, Natco, Novast Labs, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Chartwell, 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 205126
Tradename:CARISOPRODOL
Applicant:Heritage
Ingredient:carisoprodol
Patents:0
Pharmacology for NDA: 205126
Physiological EffectCentrally-mediated Muscle Relaxation
Medical Subject Heading (MeSH) Categories for 205126
Muscle Relaxants, Central
Suppliers and Packaging for NDA: 205126
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARISOPRODOL carisoprodol TABLET;ORAL 205126 ANDA Wilshire Pharmaceuticals, Inc. 52536-682 52536-682-10 100 TABLET in 1 BOTTLE (52536-682-10)
CARISOPRODOL carisoprodol TABLET;ORAL 205126 ANDA Wilshire Pharmaceuticals, Inc. 52536-688 52536-688-10 100 TABLET in 1 BOTTLE (52536-688-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 8, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength350MG
Approval Date:Jul 8, 2015TE:AARLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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