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LAMOTRIGINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA · Approved 2009-01-27

Drug application

FDA Application #

ANDA077633

Application type

Abbreviated New Drug Application (Generic)

Brand name

LAMOTRIGINE

Generic name

LAMOTRIGINE

Active ingredients

LAMOTRIGINE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS USA

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2009-01-27

Source

Authoritative

Drugs@FDA application overview

Machine

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