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FDA NDA · NDA019653

ORTHO CYCLEN-28

Sponsor: JANSSEN PHARMS

APPLICATION
NDA019653
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2017-08-09
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ORTHO CYCLEN-28 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
ORTHO CYCLEN-21Discontinued
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21

Approval history

2017-08-09Labeling · Supplement 58 · standard — Label ↗AP
2016-06-22Manufacturing (CMC) · Supplement 57 · standardAP
2015-05-01Labeling · Supplement 56 · standard — Label ↗AP
2013-10-03Labeling · Supplement 46 · standard — Label ↗AP
2013-10-02Labeling · Supplement 54 · standard — Letter ↗AP
2013-10-02Labeling · Supplement 49 · standard — Letter ↗AP
2013-10-02Labeling · Supplement 51 · standard — Letter ↗AP
2012-06-18Labeling · Supplement 48 · standard — Letter ↗AP
2008-05-30Manufacturing (CMC) · Supplement 45 — Letter ↗AP
2007-05-03Labeling · Supplement 37 · standard — Label ↗AP
2003-01-03Supplement · Supplement 35 · standard — Review ↗AP
2002-09-06Manufacturing (CMC) · Supplement 33 · standard — Review ↗AP
2002-06-03Manufacturing (CMC) · Supplement 32 · standard — Review ↗AP
2002-01-16Manufacturing (CMC) · Supplement 31 · standard — Review ↗AP
2001-07-09Manufacturing (CMC) · Supplement 30 · standard — Review ↗AP
2001-01-16Labeling · Supplement 27 · standard — Review ↗AP
2000-06-05Labeling · Supplement 25 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 24 · standard — Review ↗AP
1999-11-22Labeling · Supplement 22 · standard — Review ↗AP
1999-11-02Manufacturing (CMC) · Supplement 21 · standard — Review ↗AP
1999-10-20Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP
1999-09-30Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
1998-04-20Labeling · Supplement 17 · standard — Review ↗AP
1996-08-21Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
1996-08-02Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
1996-02-14Manufacturing (CMC) · Supplement 15 · standardAP
1996-01-29Labeling · Supplement 12 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 14 · standardAP
1995-08-21Manufacturing (CMC) · Supplement 13 · standardAP
1995-02-16Manufacturing (CMC) · Supplement 9 · standardAP
1994-06-28Labeling · Supplement 11 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 10 · standardAP
1993-09-30Labeling · Supplement 1AP
1992-10-01Manufacturing (CMC) · Supplement 6 · standardAP
1992-06-24Manufacturing (CMC) · Supplement 5 · standardAP
1991-09-17Labeling · Supplement 3AP
1991-05-23Manufacturing (CMC) · Supplement 2 · standardAP
1989-12-29Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standardAP
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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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