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METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2018-03-16

Drug application

FDA Application #

ANDA209313

Application type

Abbreviated New Drug Application (Generic)

Brand name

METFORMIN HYDROCHLORIDE

Generic name

METFORMIN ER 500 MG

Active ingredients

METFORMIN HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

GRANULES

Manufacturer

Quallent Pharmaceuticals Health LLC

First approval

2018-03-16

Source

Authoritative

Drugs@FDA application overview

Machine

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