APPLICATION
NDA020071
TYPE
NDA
ORIGINAL APPROVAL
1992-12-10
LATEST ACTION
2018-06-15
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DESOGENDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-21
DESOGENDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2016-02-11Manufacturing (CMC) · Supplement 20 · standardAP
2015-11-30Manufacturing (CMC) · Supplement 22 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 21 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-27Manufacturing (CMC) · Supplement 13 · standardAP
1998-11-19Manufacturing (CMC) · Supplement 12 · standardAP
1998-03-05Labeling · Supplement 8 · standardAP
1998-02-24Manufacturing (CMC) · Supplement 11 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 9 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 10 · standardAP
1996-07-26Labeling · Supplement 7 · standardAP
1995-04-28Labeling · Supplement 2 · standardAP
1995-04-25Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-03Labeling · Supplement 4 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 5 · standardAP
1993-03-09Labeling · Supplement 1 · standardAP
1992-12-10Type 1 - New Molecular Entity and Type 4 - New Combination · 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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