APPLICATION
NDA017810
TYPE
NDA
ORIGINAL APPROVAL
1977-08-23
LATEST ACTION
2017-07-05
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
PROSTIN E2 · ReferenceDiscontinued
DINOPROSTONE 20MG · SUPPOSITORY · VAGINAL
Approval history
2013-05-29Manufacturing (CMC) · Supplement 18 · priorityAP
1997-11-19Manufacturing (CMC) · Supplement 15 · priorityAP
1997-08-05Labeling · Supplement 16 · standardAP
1997-02-19Manufacturing (CMC) · Supplement 14 · priorityAP
1992-05-08Manufacturing (CMC) · Supplement 12 · priorityAP
1991-05-01Manufacturing (CMC) · Supplement 13 · priorityAP
1988-11-22Labeling · Supplement 11AP
1987-06-23Labeling · Supplement 10AP
1986-09-29Labeling · Supplement 8AP
1986-09-08Manufacturing (CMC) · Supplement 9 · priorityAP
1982-03-02Labeling · Supplement 7AP
1980-03-20Labeling · Supplement 6AP
1979-03-12Labeling · Supplement 4AP
1978-08-04Labeling · Supplement 3AP
1978-01-18Labeling · Supplement 2AP
1977-08-23Type 1 - New Molecular Entity · 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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