Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018985
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO-NOVUM 7/7/7-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-21 Discontinued None No No
ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/04/1984 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-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf
10/29/2015 SUPPL-63 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-62 Manufacturing (CMC)

Label is not available on this site.

10/02/2013 SUPPL-60 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-56 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-54 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-53 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-50 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-39 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/2000 SUPPL-35 Labeling

Label is not available on this site.

01/05/2000 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1999 SUPPL-33 Labeling

Label is not available on this site.

04/28/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/27/1999 SUPPL-30 Labeling

Label is not available on this site.

08/27/1999 SUPPL-29 Labeling

Label is not available on this site.

02/24/1997 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/03/1994 SUPPL-20 Labeling

Label is not available on this site.

05/18/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-14 Labeling

Label is not available on this site.

01/18/1990 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-11 Labeling

Label is not available on this site.

07/19/1989 SUPPL-10 Labeling

Label is not available on this site.

10/28/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-7 Labeling

Label is not available on this site.

02/02/1987 SUPPL-6 Labeling

Label is not available on this site.

11/23/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-3 Labeling

Label is not available on this site.

04/05/1985 SUPPL-2 Labeling

Label is not available on this site.

06/21/1984 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-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf
10/29/2015 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf
10/03/2013 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf
06/18/2012 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf

ORTHO-NOVUM 7/7/7-21

There are no Therapeutic Equivalents.

ORTHO-NOVUM 7/7/7-28

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALYACEN 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 091636 GLENMARK GENERICS
CYCLAFEM 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 076338 VINTAGE PHARMS LLC
DASETTA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 090946 NOVAST LABS LTD
NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 075478 BARR
NYLIA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 207054 AUROBINDO PHARMA LTD
ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription Yes AB 018985 JANSSEN PHARMS
PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG TABLET;ORAL-28 Prescription No AB 201510 LUPIN LTD

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