← FDA DRUG APPROVALS
FDA ANDA · ANDA212507
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release
Sponsor: HETERO LABS LTD III
APPLICATION
ANDA212507
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-02
LATEST ACTION
2020-06-02
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
2020-06-02UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.