APPLICATION
ANDA077351
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-25
LATEST ACTION
2021-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
FAMOTIDINEOver-the-counter
FAMOTIDINE 20MG · TABLET · ORAL
Approval history
2021-08-18Manufacturing (CMC) · Supplement 28 · standardAP
2021-02-18Labeling · Supplement 23 · standardAP
2016-04-26Manufacturing (CMC) · Supplement 18 · unknownAP
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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