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FDA Approval

tramadol hydrochloride

CompanyUnit Dose Services (DUNS: 831995316)

Effective Date

July 17, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tramadol(50 mg in 1 1)

Manufacturing Establishments (1)

Unit Dose Services

Labeler

Unit Dose Services

DUNS Number

831995316

Products (1)

tramadol hydrochloride

NDC Product Code

50436-0377

Application Number

ANDA075964

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 29, 2017

Ingredients

Code: 9N7R477WCKClass: ACTIBQuantity: 50 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

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