APPLICATION
NDA017553
TYPE
NDA
ORIGINAL APPROVAL
1976-02-04
LATEST ACTION
1998-01-28
ROUTE
INTRAUTERINE
DOSAGE FORM
INSERT, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROGESTASERTDiscontinued
PROGESTERONE 38MG · INSERT, EXTENDED RELEASE · INTRAUTERINE
Approval history
1998-01-28Manufacturing (CMC) · Supplement 29 · priorityAP
1995-02-03Labeling · Supplement 27 · priorityAP
1994-05-27Manufacturing (CMC) · Supplement 28 · priorityAP
1993-08-05Manufacturing (CMC) · Supplement 26 · priorityAP
1990-07-03Manufacturing (CMC) · Supplement 25 · priorityAP
1989-07-13Labeling · Supplement 24 · priorityAP
1988-03-03Manufacturing (CMC) · Supplement 23 · priorityAP
1987-05-19Labeling · Supplement 22 · priorityAP
1979-05-30Manufacturing (CMC) · Supplement 10 · priorityAP
1979-05-30Manufacturing (CMC) · Supplement 9 · priorityAP
1977-04-08Manufacturing (CMC) · Supplement 3 · priorityAP
1976-05-03Manufacturing (CMC) · Supplement 1 · priorityAP
1976-02-04Type 3 - New Dosage Form · Original · 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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