← FDA DRUG APPROVALS
FDA ANDA · ANDA201361
EQUATE OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole, sodium bicarbonate
Sponsor: PERRIGO R AND D
APPLICATION
ANDA201361
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-15
LATEST ACTION
2024-02-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter
Products
OMEPRAZOLE AND SODIUM BICARBONATEOver-the-counter
OMEPRAZOLE 20MG, SODIUM BICARBONATE 1.1GM · CAPSULE · ORAL
Approval history
2024-02-05Labeling · Supplement 6 · standardAP
2024-02-05Labeling · Supplement 4 · standardAP
2024-02-05Labeling · Supplement 17 · standardAP
2024-02-05Labeling · Supplement 15 · 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.
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