APPLICATION
ANDA075400
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-18
LATEST ACTION
2019-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
FAMOTIDINEOver-the-counter
FAMOTIDINE 10MG · TABLET · ORAL
Approval history
2019-10-22Labeling · Supplement 35 · standardAP
2010-10-30Labeling · Supplement 20AP
2008-11-24Manufacturing (CMC) · Supplement 18AP
2005-12-27Labeling · Supplement 3AP
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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