APPLICATION
ANDA207476
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-06
LATEST ACTION
2024-01-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
OMEPRAZOLE AND SODIUM BICARBONATEPrescription
OMEPRAZOLE 40MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
Approval history
2024-01-11Labeling · Supplement 12 · standardAP
2024-01-11Labeling · Supplement 8 · standardAP
2020-02-24Labeling · Supplement 5 · standardAP
2020-02-24Labeling · Supplement 1 · standardAP
2016-12-06UNKNOWN · 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.