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FDA ANDA · ANDA214489

AZILSARTAN MEDOXOMIL

Sponsor: LUPIN

APPLICATION
ANDA214489
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-20
LATEST ACTION
2024-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AZILSARTAN MEDOXOMILPrescription
AZILSARTAN KAMEDOXOMIL EQ 80MG MEDOXOMIL · TABLET · ORAL
AZILSARTAN MEDOXOMILPrescription
AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL · TABLET · ORAL

Approval history

2024-07-18Labeling · Supplement 3 · standardAP
2022-07-20UNKNOWN · Original · standard — Letter ↗AP
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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