APPLICATION
NDA010104
TYPE
NDA
ORIGINAL APPROVAL
1955-09-30
LATEST ACTION
2021-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPHYTON · ReferenceDiscontinued
PHYTONADIONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2015-03-16Manufacturing (CMC) · Supplement 30 · priorityAP
2003-06-04Labeling · Supplement 21 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 20 · priorityAP
1998-10-27Manufacturing (CMC) · Supplement 18 · priorityAP
1998-10-27Manufacturing (CMC) · Supplement 19 · priorityAP
1998-08-03Manufacturing (CMC) · Supplement 17 · priorityAP
1995-05-24Labeling · Supplement 16 · standardAP
1994-06-24Manufacturing (CMC) · Supplement 15 · priorityAP
1991-06-28Labeling · Supplement 14AP
1986-08-19Labeling · Supplement 13AP
1986-05-08Labeling · Supplement 10AP
1986-01-13Labeling · Supplement 11AP
1981-06-17Manufacturing (CMC) · Supplement 9 · priorityAP
1980-03-07Manufacturing (CMC) · Supplement 8 · priorityAP
1979-09-18Manufacturing (CMC) · Supplement 7 · priorityAP
1979-06-28Labeling · Supplement 6AP
1976-08-18Manufacturing (CMC) · Supplement 4 · priorityAP
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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