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Soma

These highlights do not include all the information needed to use SOMA safely and effectively. See full prescribing information for SOMA. SOMA (carisoprodol) Tablets for Oral use Initial U.S. Approval: 1959

Approved
Approval ID

6543c6ba-852e-40fb-b7ec-1331b9c83656

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carisoprodol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-606
Application NumberNDA011792
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 16, 2009
FDA Product Classification

INGREDIENTS (1)

CARISOPRODOLActive
Quantity: 250 mg in 1 1
Code: 21925K482H
Classification: ACTIB

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Soma - FDA Drug Approval Details