APPLICATION
ANDA206531
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-26
LATEST ACTION
2022-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
FAMOTIDINEOver-the-counter
FAMOTIDINE 20MG · TABLET · ORAL
FAMOTIDINEOver-the-counter
FAMOTIDINE 10MG · TABLET · ORAL
Approval history
2022-08-25Labeling · Supplement 18 · standardAP
2022-07-15Manufacturing (CMC) · Supplement 17 · unknownAP
2019-09-11Labeling · Supplement 1 · standardAP
2019-09-11Labeling · Supplement 7 · standardAP
2016-04-26UNKNOWN · 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.
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