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FDA ANDA · ANDA207193

KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM

esomeprazole

Sponsor: PERRIGO R AND D

APPLICATION
ANDA207193
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-18
LATEST ACTION
2020-01-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

ESOMEPRAZOLE MAGNESIUMOver-the-counter
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2020-01-21Labeling · Supplement 11 · standard — Review ↗AP
2020-01-21Labeling · Supplement 3 · standard — Review ↗AP
2017-08-18UNKNOWN · 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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