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LAMOTRIGINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2009-01-22

Drug application

FDA Application #

ANDA078009

Application type

Abbreviated New Drug Application (Generic)

Brand name

LAMOTRIGINE

Generic name

LAMOTRIGINE

Active ingredients

LAMOTRIGINE

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS USA INC

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2009-01-22

Source

Authoritative

Drugs@FDA application overview

Machine

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