APPLICATION
ANDA212977
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-10
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 8 · standardAP
2022-03-04Labeling · Supplement 4 · standardAP
2020-12-10UNKNOWN · 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.