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FDA Approval

Metformin Hydrochloride

CompanyMedVantx, Inc. (DUNS: 806427725)

Effective Date

June 11, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(500 mg in 1 1)

Registrants (1)

TEVA Pharmaceuticals USA Inc

DUNS Number

118234421

Manufacturing Establishments (1)

Blenheim Pharmacal, Inc.

Labeler

MedVantx, Inc.

Registrant

TEVA Pharmaceuticals USA Inc

DUNS Number

171434587

Products (1)

Metformin Hydrochloride

NDC Product Code

66116-433

Application Number

ANDA076269

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 15, 2007

Ingredients

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

ETHYLCELLULOSE (7 MPA.S)Inactive

Code: H3UP11403CClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

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