← FDA DRUG APPROVALS

FDA ANDA · ANDA211571

ESOMEPRAZOLE MAGNESIUM

Sponsor: DR REDDYS

APPLICATION
ANDA211571
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-14
LATEST ACTION
2020-05-14
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

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

Approval history

2020-05-14UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →