Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019697
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO TRI-CYCLEN ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription AB Yes Yes
ORTHO TRI-CYCLEN ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-21 Discontinued None No 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
07/03/1992 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-54 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
05/01/2015 SUPPL-52 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-50 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-47 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/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf
10/02/2013 SUPPL-45 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-44 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-42 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-41 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-34 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-32 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019697_s032_ORTHOCYCLEN.pdf
09/06/2002 SUPPL-30 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s030_ORTHOCYCLEN.pdf
06/03/2002 SUPPL-29 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s029_ORTHOCYCLEN.pdf
01/16/2002 SUPPL-28 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019697_s028_ORTHO CYCLEN.pdf
07/09/2001 SUPPL-27 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s027_ORTHO CYCLEN.pdf
08/30/2000 SUPPL-25 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s025_ORTHO CYCLEN.pdf
01/16/2001 SUPPL-24 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019697_s024_ORTHO CYCLEN.pdf
06/05/2000 SUPPL-22 Labeling

Label is not available on this site.

01/05/2000 SUPPL-21 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019697_s021_ORTHO CYCLEN.pdf
09/30/1999 SUPPL-19 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s019_ORTHOCYCLEN.pdf
11/22/1999 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s018_ORTHO CYCLEN.pdf
11/02/1999 SUPPL-16 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s016_ORTHOCYCLEN.pdf
10/20/1999 SUPPL-15 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019697_s015_ORTHOCYCLEN.pdf
08/21/1996 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s013_ORTHOCYCLEN.pdf
04/20/1998 SUPPL-12 Labeling

Label is not available on this site.

08/02/1996 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s011_ORTHO CYCLEN.pdf
02/14/1996 SUPPL-10 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s010_ORTHOTRICYCLEN.pdf
02/07/1996 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s009_ORTHOTRICYCLEN.pdf
11/30/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/21/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1995 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/29/1996 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019697_s005_ORTHOTRICYCLEN.pdf
12/28/1994 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019697_s004_ORTHOTRICYCLEN.pdf
06/28/1994 SUPPL-3 Labeling

Label is not available on this site.

02/16/1995 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/01969_s002_Orthotricyclen.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019653s058,019697s054lbl.pdf
05/01/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf
10/03/2013 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046, 019697Orig1s042lbl.pdf
10/02/2013 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019653Orig1s046,019697Orig1s042lbl.pdf
06/18/2012 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019653s048lbl.pdf
05/03/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019653s037,019697s034lbl.pdf

ORTHO TRI-CYCLEN

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 203870 AMNEAL PHARMS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 200494 GLENMARK GENERICS
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205588 LUPIN LTD
NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 201897 MYLAN LABS LTD
ORTHO TRI-CYCLEN ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription Yes AB 019697 JANSSEN PHARMS
TRI-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 090793 XIROMED
TRI-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 090524 NOVAST LABS LTD
TRI-MILI ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 205441 AUROBINDO PHARMA LTD
TRI-PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 076335 VINTAGE PHARMS LLC
TRI-SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG TABLET;ORAL-28 Prescription No AB 075808 BARR

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