← FDA Drug Approvals (Drugs@FDA)

IRBESARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2018-04-17

Drug application

FDA Application #

ANDA204740

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

AMNEAL PHARMS

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2018-04-17

Source

Authoritative

Drugs@FDA application overview

Machine

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