Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017735
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MODICON 28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG 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
05/14/1976 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-118 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-117 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-116 Manufacturing (CMC)

Label is not available on this site.

10/02/2013 SUPPL-114 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-110 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-108 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-107 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-104 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-93 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/2000 SUPPL-89 Labeling

Label is not available on this site.

01/05/2000 SUPPL-88 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1999 SUPPL-87 Labeling

Label is not available on this site.

04/28/1998 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

01/06/1999 SUPPL-84 Labeling

Label is not available on this site.

08/27/1999 SUPPL-83 Labeling

Label is not available on this site.

02/24/1997 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1997 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1996 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1996 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1995 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

09/07/1995 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1993 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

01/04/1994 SUPPL-74 Labeling

Label is not available on this site.

05/18/1993 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-72 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/18/1991 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1991 SUPPL-69 Labeling

Label is not available on this site.

01/18/1990 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-66 Labeling

Label is not available on this site.

07/19/1989 SUPPL-65 Labeling

Label is not available on this site.

10/28/1988 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1988 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-62 Labeling

Label is not available on this site.

02/26/1987 SUPPL-61 Labeling

Label is not available on this site.

11/23/1987 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1985 SUPPL-58 Labeling

Label is not available on this site.

04/05/1985 SUPPL-57 Labeling

Label is not available on this site.

06/21/1984 SUPPL-56 Labeling

Label is not available on this site.

01/30/1984 SUPPL-55 Labeling

Label is not available on this site.

09/29/1983 SUPPL-54 Labeling

Label is not available on this site.

06/15/1983 SUPPL-52 Labeling

Label is not available on this site.

06/09/1983 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1982 SUPPL-49 Labeling

Label is not available on this site.

11/20/1980 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1980 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1980 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

03/28/1980 SUPPL-42 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/24/1980 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/13/1979 SUPPL-40 Labeling

Label is not available on this site.

11/08/1979 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1979 SUPPL-38 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/15/1979 SUPPL-37 Labeling

Label is not available on this site.

10/19/1979 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1980 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-32 Labeling

Label is not available on this site.

06/19/1979 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1978 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1977 SUPPL-3 Labeling

Label is not available on this site.

07/15/1977 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/30/1976 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-118 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf
10/29/2015 SUPPL-117 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf
10/03/2013 SUPPL-104 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf
06/18/2012 SUPPL-107 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf

MODICON 28

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREVICON 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 017743 ALLERGAN SALES LLC
CYCLAFEM 0.5/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 203413 VINTAGE PHARMS
CYONANZ ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 207055 AUROBINDO PHARMA LTD
MODICON 28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription Yes AB 017735 JANSSEN PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 070686 MAYNE PHARMA
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 200488 MYLAN LABS LTD
NORTREL 0.5/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 072695 BARR
WERA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 091204 NOVAST LABS LTD

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