Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017919
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG 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
06/23/1977 ORIG-1 Approval Type 3 - New Dosage Form 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-100 Labeling-Package Insert Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf
10/29/2015 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf
09/11/2014 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

10/02/2013 SUPPL-96 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-92 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-90 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-89 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf
10/03/2013 SUPPL-86 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf
06/03/2002 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/2000 SUPPL-71 Labeling

Label is not available on this site.

01/05/2000 SUPPL-70 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1999 SUPPL-69 Labeling

Label is not available on this site.

04/28/1998 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

01/06/1999 SUPPL-66 Labeling

Label is not available on this site.

08/27/1999 SUPPL-65 Labeling

Label is not available on this site.

02/24/1997 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1997 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1993 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/04/1994 SUPPL-56 Labeling

Label is not available on this site.

05/18/1993 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-49 Labeling

Label is not available on this site.

01/18/1990 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-46 Labeling

Label is not available on this site.

07/19/1989 SUPPL-45 Labeling

Label is not available on this site.

10/28/1988 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-42 Labeling

Label is not available on this site.

02/26/1987 SUPPL-41 Labeling

Label is not available on this site.

11/23/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-38 Labeling

Label is not available on this site.

04/05/1985 SUPPL-37 Labeling

Label is not available on this site.

06/21/1984 SUPPL-36 Labeling

Label is not available on this site.

01/30/1984 SUPPL-35 Labeling

Label is not available on this site.

09/29/1983 SUPPL-34 Labeling

Label is not available on this site.

06/15/1983 SUPPL-32 Labeling

Label is not available on this site.

06/09/1983 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1982 SUPPL-29 Labeling

Label is not available on this site.

11/12/1980 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1980 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1980 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/24/1980 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/05/1979 SUPPL-21 Labeling

Label is not available on this site.

12/05/1979 SUPPL-20 Labeling

Label is not available on this site.

11/08/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1979 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/19/1979 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1980 SUPPL-4 Labeling

Label is not available on this site.

07/31/1978 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1978 SUPPL-1 Manufacturing (CMC)-Control

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-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf
08/09/2017 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf
10/29/2015 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf
10/03/2013 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf
06/18/2012 SUPPL-89 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf

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