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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 012366

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NDA 012366 describes SOMA COMPOUND W/ CODEINE, which is a drug marketed by Meda Pharms and is included in one NDA. Additional details are available on the SOMA COMPOUND W/ CODEINE profile page.

The generic ingredient in SOMA COMPOUND W/ CODEINE is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.
Summary for 012366
Paragraph IV (Patent) Challenges for 012366
Tradename Dosage Ingredient NDA Submissiondate
SOMA COMPOUND W/ CODEINE TABLET;ORAL aspirin; carisoprodol; codeine phosphate 012366

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 11, 1983TE:RLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
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