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INDOMETHACIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2010-12-01

Drug application

FDA Application #

ANDA091549

Application type

Abbreviated New Drug Application (Generic)

Brand name

INDOMETHACIN

Generic name

INDOMETHACIN

Active ingredients

INDOMETHACIN

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL PHARMS

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2010-12-01

Source

Authoritative

Drugs@FDA application overview

Machine

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