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PRAMIPEXOLE DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2019-01-02

Drug application

FDA Application #

ANDA204518

Application type

Abbreviated New Drug Application (Generic)

Brand name

PRAMIPEXOLE DIHYDROCHLORIDE

Generic name

PRAMIPEXOLE DIHYDROCHLORIDE

Active ingredients

PRAMIPEXOLE DIHYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2019-01-02

Source

Authoritative

Drugs@FDA application overview

Machine

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