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FDA ANDA · ANDA211752

ESOMEPRAZOLE MAGNESIUM

Sponsor: CIPLA

APPLICATION
ANDA211752
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-23
LATEST ACTION
2023-09-11
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2023-09-11Labeling · Supplement 6 · standardAP
2023-09-11Labeling · Supplement 4 · standardAP
2023-09-11Labeling · Supplement 2 · standardAP
2023-09-11Labeling · Supplement 3 · standardAP
2020-03-23UNKNOWN · 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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