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IRBESARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2012-09-27

Drug application

FDA Application #

ANDA203071

Application type

Abbreviated New Drug Application (Generic)

Brand name

IRBESARTAN

Generic name

IRBESARTAN

Active ingredients

IRBESARTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

PRINSTON INC

Manufacturer

Solco Healthcare U.S., LLC

First approval

2012-09-27

Source

Authoritative

Drugs@FDA application overview

Machine

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