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FDA NDA · NDA021241

ORTHO TRI-CYCLEN LO

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021241
TYPE
NDA
ORIGINAL APPROVAL
2002-08-22
LATEST ACTION
2017-08-09
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ORTHO TRI-CYCLEN LO · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2017-08-09Labeling · Supplement 27 · standard — Label ↗AP
2015-07-31Labeling · Supplement 25 · standard — Label ↗AP
2012-06-18Labeling · Supplement 17 · standard — Letter ↗AP
2003-01-03Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2002-08-22Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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