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GABAPENTIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2011-02-11

Drug application

FDA Application #

ANDA078926

Application type

Abbreviated New Drug Application (Generic)

Brand name

GABAPENTIN

Generic name

GABAPENTIN

Active ingredients

GABAPENTIN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS USA INC

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2011-02-11

Source

Authoritative

Drugs@FDA application overview

Machine

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