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Details for New Drug Application (NDA): 205085

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NDA 205085 describes CARISOPRODOL, which is a drug marketed by Strides Pharma, Able, Ingenus Pharms Nj, Hikma Intl Pharms, Sandoz, Indicus Pharma, Watson Labs, Vintage Pharms, Sun Pharm Inds, Sun Pharm Inds Ltd, Sciegen Pharms Inc, Accelrx Labs, Orient Pharma Co Ltd, Natco Pharma Ltd, Oxford Pharms, Pioneer Pharms, Aurobindo Pharma, Corepharma, and Heritage Pharms Inc, and is included in thirty NDAs. It is available from forty-six suppliers. Additional details are available on the CARISOPRODOL profile page.

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

Summary for NDA: 205085

Orient Pharma Co Ltd
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 205085

Suppliers and Packaging for NDA: 205085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 205085 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-705 59746-705-01 100 TABLET in 1 BOTTLE (59746-705-01)
TABLET;ORAL 205085 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-705 59746-705-05 500 TABLET in 1 BOTTLE (59746-705-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength350MG
Approval Date:Oct 28, 2014TE:AARLD:No

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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.