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FDA ANDA · ANDA207265

ESOMEPRAZOLE MAGNESIUM

Sponsor: HEC PHARM

APPLICATION
ANDA207265
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-18
LATEST ACTION
2019-01-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued

Products

ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2019-01-25Manufacturing (CMC) · Supplement 1 · standardAP
2018-05-18UNKNOWN · Original · standardAP
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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