Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019697
Company: JANSSEN PHARMS
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| 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |
| ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-58 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019697s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019697Orig1s058ltr.pdf | |
| 06/15/2023 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019697s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019697Orig1s056,s057ltr.pdf | |
| 06/15/2023 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019697s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019697Orig1s056,s057ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019697s056s057lbl.pdf | |
| 06/15/2023 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019697s056s057lbl.pdf | |
| 04/29/2022 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019697s058lbl.pdf | |
| 04/29/2022 | SUPPL-58 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019697s058lbl.pdf | |
| 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 |