APPLICATION
NDA020411
TYPE
NDA
ORIGINAL APPROVAL
1995-03-30
LATEST ACTION
2020-07-07
ROUTE
VAGINAL
DOSAGE FORM
INSERT, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CERVIDIL · ReferencePrescription
DINOPROSTONE 10MG · INSERT, EXTENDED RELEASE · VAGINAL
Approval history
2002-01-25Manufacturing (CMC) · Supplement 20 · standardAP
2001-12-21Manufacturing (CMC) · Supplement 19 · standardAP
2000-11-06Manufacturing (CMC) · Supplement 17 · standardAP
2000-06-30Manufacturing (CMC) · Supplement 15 · standardAP
2000-06-27Manufacturing (CMC) · Supplement 13 · standardAP
2000-04-13Labeling · Supplement 16 · standardAP
2000-02-11Labeling · Supplement 14 · standardAP
1999-11-05Labeling · Supplement 11 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 10 · standardAP
1999-08-24Manufacturing (CMC) · Supplement 5 · standardAP
1999-03-19Manufacturing (CMC) · Supplement 9 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 8 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 7 · standardAP
1997-12-24Manufacturing (CMC) · Supplement 6 · standardAP
1997-12-18Manufacturing (CMC) · Supplement 4 · standardAP
1996-04-04Manufacturing (CMC) · Supplement 3 · standardAP
1996-02-22Labeling · Supplement 1 · standardAP
1995-08-29Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-30Type 3 - New Dosage Form · 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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