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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021241
Company: JANSSEN PHARMS

Products on NDA 021241

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORTHO TRI-CYCLEN LO	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL-28	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021241

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21241lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021241_sooo_Orthotricyclene.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021241s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021241Orig1s027ltr.pdf
07/31/2015	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021241s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021241Orig1s025ltr.pdf
06/18/2012	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021241s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf
01/03/2003	SUPPL-3	Manufacturing (CMC)	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021241_s003_OrthoTOC.html

Labels for NDA 021241

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021241s027lbl.pdf
07/31/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021241s025lbl.pdf
06/18/2012	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021241s017lbl.pdf
08/22/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21241lbl.pdf

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