Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021690
Company: ORTHO MCNEIL PHARM

Products on NDA 021690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORTHO TRI-CYCLEN 21	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	TABLET; ORAL-21	Prescription	None	No	No
ORTHO TRI-CYCLEN 28	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	TABLET; ORAL-28	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2005	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Label (PDF) Letter (PDF) Patient Package Insert (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021690ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021690s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf

Labels for NDA 021690

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf
05/13/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690lbl.pdf