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LAMOTRIGINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2013-01-18

Drug application

FDA Application #

ANDA201791

Application type

Abbreviated New Drug Application (Generic)

Brand name

LAMOTRIGINE

Generic name

LAMOTRIGINE EXTENDED RELEASE

Active ingredients

LAMOTRIGINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Discontinued

Sponsor

PH HEALTH

Manufacturer

Par Health USA, LLC

First approval

2013-01-18

Source

Authoritative

Drugs@FDA application overview

Machine

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