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FDA ANDA · ANDA090720

IRBESARTAN

Sponsor: WATSON LABS INC

APPLICATION
ANDA090720
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-12
LATEST ACTION
2022-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IRBESARTANDiscontinued
IRBESARTAN 150MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 300MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 75MG · TABLET · ORAL

Approval history

2022-01-26Labeling · Supplement 3 · standardAP
2018-11-02Labeling · Supplement 2 · standardAP
2012-10-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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