APPLICATION
NDA020238
TYPE
NDA
ORIGINAL APPROVAL
1995-06-19
LATEST ACTION
2022-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter, Discontinued
Products
TAGAMET HB · ReferenceOver-the-counter
CIMETIDINE 200MG · TABLET · ORAL
TAGAMET HB · ReferenceDiscontinued
CIMETIDINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2014-09-26Manufacturing (CMC) · Supplement 20 · standardAP
1999-08-11Manufacturing (CMC) · Supplement 12 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 11 · standardAP
1998-12-10Manufacturing (CMC) · Supplement 9 · standardAP
1998-11-06Manufacturing (CMC) · Supplement 10 · standardAP
1998-06-05Efficacy · Supplement 6 · unknownAP
1998-03-05Manufacturing (CMC) · Supplement 7 · standardAP
1997-04-15Manufacturing (CMC) · Supplement 5 · standardAP
1996-08-21Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-23Manufacturing (CMC) · Supplement 2 · standardAP
1996-03-29Labeling · Supplement 3 · standardAP
1995-11-15Efficacy · Supplement 4 · unknownAP
1995-06-19Type 8 - Partial Rx to OTC Switch · 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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