APPLICATION
NDA017020
TYPE
NDA
ORIGINAL APPROVAL
1972-08-11
LATEST ACTION
1987-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PANWARFINDiscontinued
WARFARIN SODIUM 7.5MG · TABLET · ORAL
PANWARFINDiscontinued
WARFARIN SODIUM 2.5MG · TABLET · ORAL
PANWARFINDiscontinued
WARFARIN SODIUM 10MG · TABLET · ORAL
PANWARFINDiscontinued
WARFARIN SODIUM 5MG · TABLET · ORAL
PANWARFINDiscontinued
WARFARIN SODIUM 2MG · TABLET · ORAL
Approval history
1987-02-25Labeling · Supplement 12 · standardAP
1984-09-25Manufacturing (CMC) · Supplement 11 · standardAP
1982-06-29Manufacturing (CMC) · Supplement 10 · standardAP
1980-09-26Labeling · Supplement 8 · standardAP
1979-03-30Manufacturing (CMC) · Supplement 7 · standardAP
1979-01-11Manufacturing (CMC) · Supplement 6 · standardAP
1976-04-28Labeling · Supplement 4 · standardAP
1975-12-12Labeling · Supplement 3 · standardAP
1975-06-23Manufacturing (CMC) · Supplement 2 · standardAP
1975-03-03REMS · Supplement 1 · standardAP
1972-08-11Type 5 - New Formulation or New Manufacturer · 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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