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FDA NDA · NDA020301

ORTHO-CEPT

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020301
TYPE
NDA
ORIGINAL APPROVAL
1992-12-14
LATEST ACTION
2017-08-09
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ORTHO-CEPT · ReferenceDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
ORTHO-CEPT · ReferenceDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21

Approval history

2017-08-09Labeling · Supplement 37 · standard — Label ↗AP
2015-12-01Labeling · Supplement 36 · standard — Label ↗AP
2014-04-08Manufacturing (CMC) · Supplement 33 · standardAP
2013-10-03Labeling · Supplement 25 · standard — Label ↗AP
2013-10-02Labeling · Supplement 28 · standard — Letter ↗AP
2013-10-02Labeling · Supplement 34 · standard — Letter ↗AP
2013-10-02Labeling · Supplement 30 · standard — Letter ↗AP
2012-06-18Labeling · Supplement 27 · standard — Label ↗AP
2002-02-21Manufacturing (CMC) · Supplement 18 · standardAP
2001-06-19Labeling · Supplement 15 · standardAP
2001-06-07Manufacturing (CMC) · Supplement 16 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 14 · standardAP
1999-03-03Manufacturing (CMC) · Supplement 12 · standardAP
1998-11-19Manufacturing (CMC) · Supplement 11 · standardAP
1998-11-19Manufacturing (CMC) · Supplement 10 · standardAP
1997-02-04Labeling · Supplement 9 · standardAP
1996-12-04Manufacturing (CMC) · Supplement 5 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 7 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 6 · standardAP
1996-02-14Labeling · Supplement 8 · standardAP
1995-06-02Labeling · Supplement 4 · standardAP
1994-01-05Manufacturing (CMC) · Supplement 2 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-14Type 5 - New Formulation or New Manufacturer · Original · standardAP
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