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MEMANTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PURACAP LABS BLU · Approved 2020-12-11

Drug application

FDA Application #

ANDA210587

Application type

Abbreviated New Drug Application (Generic)

Brand name

MEMANTINE HYDROCHLORIDE

Generic name

MEMANTINE HYDROCHLORIDE

Active ingredients

MEMANTINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

PURACAP LABS BLU

Manufacturer

POLYGEN PHARMACEUTICALS INC.

First approval

2020-12-11

Source

Authoritative

Drugs@FDA application overview

Machine

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