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Tramadol Hydrochloride

Tramadol Hydrochloride Tablets

Approved
Approval ID

340a7760-50b1-4825-9766-eaaad0dd7712

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 9, 2010

Manufacturers
FDA

Keltman Pharmaceuticals Inc.

DUNS: 362861077

Products 1

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

Tramadol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68387-900
Application NumberANDA076003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2010
FDA Product Classification

INGREDIENTS (1)

TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB

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Tramadol Hydrochloride - FDA Drug Approval Details