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FDA ANDA · ANDA075512

FAMOTIDINE

Sponsor: P AND L

APPLICATION
ANDA075512
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-26
LATEST ACTION
2019-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

FAMOTIDINEOver-the-counter
FAMOTIDINE 10MG · TABLET · ORAL

Approval history

2019-12-18Labeling · Supplement 20 · standardAP
2019-12-18Labeling · Supplement 17 · standardAP
2008-06-18Labeling · Supplement 9AP
2008-03-26Labeling · Supplement 8AP
2002-05-08Manufacturing (CMC) · Supplement 3AP
2002-01-17Manufacturing (CMC) · Supplement 2AP
2002-01-17Manufacturing (CMC) · Supplement 1AP
2001-07-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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