Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English