← FDA DRUG APPROVALS

FDA NDA · NDA019697

ORTHO TRI-CYCLEN

Sponsor: JANSSEN PHARMS

APPLICATION
NDA019697
TYPE
NDA
ORIGINAL APPROVAL
1992-07-03
LATEST ACTION
2023-06-15
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ORTHO TRI-CYCLEN · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
ORTHO TRI-CYCLENDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21

Approval history

2023-06-15Labeling · Supplement 56 · standardLabelAP
2023-06-15Labeling · Supplement 57 · standardLabelAP
2022-04-29Labeling · Supplement 58 · standardLabelAP
2017-08-09Labeling · Supplement 54 · standardLabelAP
2015-05-01Labeling · Supplement 52 · standardLetterAP
2013-10-03Labeling · Supplement 42 · standardLabelAP
2013-10-02Labeling · Supplement 47 · standardLetterAP
2013-10-02Labeling · Supplement 45 · standardLetterAP
2013-10-02Labeling · Supplement 50 · standardLetterAP
2012-06-18Labeling · Supplement 44 · standardLetterAP
2008-05-30Manufacturing (CMC) · Supplement 41LetterAP
2007-05-03Labeling · Supplement 34 · standardLetterAP
2003-01-03Manufacturing (CMC) · Supplement 32 · standardReviewAP
2002-09-06Manufacturing (CMC) · Supplement 30 · standardReviewAP
2002-06-03Manufacturing (CMC) · Supplement 29 · standardReviewAP
2002-01-16Manufacturing (CMC) · Supplement 28 · standardReviewAP
2001-07-09Manufacturing (CMC) · Supplement 27 · standardReviewAP
2001-01-16Labeling · Supplement 24 · standardReviewAP
2000-08-30Manufacturing (CMC) · Supplement 25 · standardReviewAP
2000-06-05Labeling · Supplement 22 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 21 · standardReviewAP
1999-11-22Labeling · Supplement 18 · standardReviewAP
1999-11-02Manufacturing (CMC) · Supplement 16 · standardReviewAP
1999-10-20Manufacturing (CMC) · Supplement 15 · standardReviewAP
1999-09-30Manufacturing (CMC) · Supplement 19 · standardReviewAP
1998-04-20Labeling · Supplement 12 · standardAP
1996-08-21Manufacturing (CMC) · Supplement 13 · standardReviewAP
1996-08-02Manufacturing (CMC) · Supplement 11 · standardReviewAP
1996-02-14Manufacturing (CMC) · Supplement 10 · standardReviewAP
1996-02-07Manufacturing (CMC) · Supplement 9 · standardReviewAP
1996-01-29Labeling · Supplement 5 · standardReviewAP
1995-11-30Manufacturing (CMC) · Supplement 8 · standardAP
1995-08-21Manufacturing (CMC) · Supplement 7 · standardAP
1995-08-21Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-16Manufacturing (CMC) · Supplement 2 · standardReviewAP
1994-12-28Manufacturing (CMC) · Supplement 4 · standardReviewAP
1994-06-28Labeling · Supplement 3 · standardAP
1992-07-03Type 3 - New Dosage Form · Original · standardPediatric Medical ReviewAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →