APPLICATION
NDA019369
TYPE
NDA
ORIGINAL APPROVAL
1986-09-30
LATEST ACTION
1995-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TEGISONDiscontinued
ETRETINATE 10MG · CAPSULE · ORAL
TEGISONDiscontinued
ETRETINATE 25MG · CAPSULE · ORAL
Approval history
1995-02-16Manufacturing (CMC) · Supplement 11 · priorityAP
1994-01-12Manufacturing (CMC) · Supplement 10 · priorityAP
1991-10-08Manufacturing (CMC) · Supplement 8 · priorityAP
1990-10-16Manufacturing (CMC) · Supplement 7 · priorityAP
1988-08-31Manufacturing (CMC) · Supplement 6 · priorityAP
1988-08-05Manufacturing (CMC) · Supplement 5 · priorityAP
1988-05-27Labeling · Supplement 3AP
1988-03-25Manufacturing (CMC) · Supplement 4 · priorityAP
1987-04-29Labeling · Supplement 1AP
1987-04-02Manufacturing (CMC) · Supplement 2 · 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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