Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019653
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO CYCLEN-21 ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-21 Discontinued None No No
ORTHO CYCLEN-28 ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG TABLET;ORAL-28 Discontinued None Yes 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
12/29/1989 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019653s058,019697s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019653Orig1s058,19697Orig1s054ltr.pdf
06/22/2016 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

05/01/2015 SUPPL-56 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
10/02/2013 SUPPL-54 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf
10/02/2013 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf
10/02/2013 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf
06/18/2012 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf
10/03/2013 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf
05/30/2008 SUPPL-45 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653s045,019697s041ltr.pdf
05/03/2007 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019653s037,019697s034ltr.pdf
01/03/2003 SUPPL-35 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019653_s035_ORTHOCYCLEN.pdf
09/06/2002 SUPPL-33 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s033_ORTHOCYCLEN.pdf
06/03/2002 SUPPL-32 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s032_ORTHOCYCLEN.pdf
01/16/2002 SUPPL-31 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019653_s031_ORTHO CYCLEN.pdf
07/09/2001 SUPPL-30 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s030_ORTHO CYCLEN.pdf
01/16/2001 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019653_s027_ORTHO CYCLEN.pdf
06/05/2000 SUPPL-25 Labeling

Label is not available on this site.

01/05/2000 SUPPL-24 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019653_s024_ORTHO CYCLEN.pdf
09/30/1999 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s023_ORTHOCYCLEN.pdf
11/22/1999 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s022_ORTHO CYCLEN.pdf
11/02/1999 SUPPL-21 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s021_ORTHOCYCLEN.pdf
10/20/1999 SUPPL-20 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019653_s020_ORTHOCYCLEN.pdf
08/21/1996 SUPPL-18 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s018_ORTHO CYCLEN.pdf
04/20/1998 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019653_s017_ORTHOCYCLEN.pdf
08/02/1996 SUPPL-16 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019653_s016_ORTHO CYCLEN.pdf
02/14/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/21/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1996 SUPPL-12 Labeling

Label is not available on this site.

06/28/1994 SUPPL-11 Labeling

Label is not available on this site.

11/04/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1992 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/17/1991 SUPPL-3 Labeling

Label is not available on this site.

05/23/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019653s058,019697s054lbl.pdf
05/01/2015 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf
10/03/2013 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf
06/18/2012 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf
05/03/2007 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf

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