APPLICATION
ANDA203306
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-13
LATEST ACTION
2020-07-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Over-the-counter
Products
LANSOPRAZOLEOver-the-counter
LANSOPRAZOLE 15MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2020-07-21Labeling · Supplement 4 · standardAP
2020-07-21Labeling · Supplement 2 · standardAP
2020-07-21Labeling · Supplement 3 · standardAP
2016-01-13UNKNOWN · OriginalAP
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.