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FDA Approval

tramadol hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 5, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tramadol(50 mg in 1 1)

Products1

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

tramadol hydrochloride

Product Details

NDC Product Code
33261-483
Application Number
ANDA075964
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 5, 2012
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TramadolActive
Code: 9N7R477WCKClass: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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tramadol hydrochloride - FDA Approval | MedPath