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RANOLAZINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 2013-07-29

Drug application

FDA Application #

ANDA201046

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

CHARTWELL RX

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2013-07-29

Source

Authoritative

Drugs@FDA application overview

Machine

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