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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020301
Company: JANSSEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-CEPT DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-21 Discontinued None Yes No
ORTHO-CEPT DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-28 Discontinued None Yes No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
12/14/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020301s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020301Orig1s037ltr.pdf
12/01/2015 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020301Orig1s036ltr.pdf
10/02/2013 SUPPL-34 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
04/08/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
10/02/2013 SUPPL-30 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-28 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-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf
10/03/2013 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf
02/21/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/07/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
06/19/2001 SUPPL-15 Labeling

Label is not available on this site.
01/05/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
03/03/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
11/19/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
11/19/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/04/1997 SUPPL-9 Labeling

Label is not available on this site.
02/14/1996 SUPPL-8 Labeling

Label is not available on this site.
03/04/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
02/21/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
12/04/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
06/02/1995 SUPPL-4 Labeling

Label is not available on this site.
11/04/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/05/1994 SUPPL-2 Manufacturing (CMC)

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-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020301s037lbl.pdf
12/01/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf
10/03/2013 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf
06/18/2012 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf
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