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RANOLAZINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2023-03-16

Drug application

FDA Application #

ANDA213083

Application type

Abbreviated New Drug Application (Generic)

Brand name

RANOLAZINE

Generic name

RANOLAZINE

Active ingredients

RANOLAZINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

UNICHEM

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

First approval

2023-03-16

Source

Authoritative

Drugs@FDA application overview

Machine

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