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FDA Approval

Metformin Hydrochloride

CompanyAphena Pharma Solutions - Tennessee, LLC (DUNS: 128385585)

Effective Date

November 9, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(750 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Labeler

Aphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Products (1)

Metformin Hydrochloride

NDC Product Code

71610-740

Application Number

ANDA078596

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 9, 2023

Ingredients

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

MetforminActive

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

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