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FDA Approval

Metformin Hydrochloride

CompanyAmneal Pharmaceuticals of New York LLC (DUNS: 123797875)

Effective Date

March 18, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(500 mg in 1 1)

Manufacturing Establishments (1)

Amneal Pharmaceuticals, LLC

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

969951594

Products (2)

Metformin Hydrochloride

NDC Product Code

53746-178

Application Number

ANDA078596

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 18, 2021

Ingredients

MetforminActive

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

Metformin Hydrochloride

NDC Product Code

53746-179

Application Number

ANDA078596

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 18, 2021

Ingredients

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 750 mg in 1 1

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