Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021180
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORTHO EVRA | ETHINYL ESTRADIOL; NORELGESTROMIN | 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/20/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_Ortho%20EVRA_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021180Orig1s048ltr.pdf | |
| 10/22/2015 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021180Orig1s047ltr.pdf | |
| 04/11/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021180Orig1s046ltr.pdf | |
| 07/01/2013 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021180Orig1s044ltr.pdf | |
| 08/22/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021180Orig1s043ltr.pdf | |
| 04/12/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/2011 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s040ltr.pdf | |
| 03/23/2011 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s039ltr.pdf | |
| 07/26/2011 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s038ltr.pdf | |
| 04/12/2013 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/2010 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021180s035ltr.pdf | |
| 12/01/2009 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s034ltr.pdf | |
| 09/11/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s033ltr.pdf | |
| 10/30/2008 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,%20s030,%20s031ltr.pdf | |
| 10/30/2008 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf | |
| 07/29/2009 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s029ltr.pdf | |
| 10/30/2008 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf | |
| 01/18/2008 | SUPPL-26 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf | |
| 09/20/2006 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s022ltr.pdf | |
| 05/17/2006 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s020LTR.pdf |
| 11/10/2005 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s019ltr.pdf | |
| 05/06/2005 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s015ltr.pdf | |
| 11/24/2004 | SUPPL-14 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180s014ltr.pdf |
| 02/04/2004 | SUPPL-8 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021180_s008_ORTHO EVRA.pdf |
| 06/18/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21180_S005_OrthoEvraTOC.cfm |
| 10/02/2002 | SUPPL-4 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s004_OrthoTOC.cfm |
| 11/14/2002 | SUPPL-3 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s003_OrthoTOC.cfm |
| 08/09/2002 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s002_ORTHO EVRA.pdf |
| 03/04/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s001_ORTHO EVRA.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf | |
| 10/22/2015 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf | |
| 04/11/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf | |
| 07/01/2013 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf | |
| 08/22/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf | |
| 12/28/2011 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf | |
| 07/26/2011 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf | |
| 03/23/2011 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf | |
| 04/13/2010 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf | |
| 12/01/2009 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf | |
| 09/11/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf | |
| 07/29/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf | |
| 10/30/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf | |
| 10/30/2008 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf | |
| 10/30/2008 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf | |
| 01/18/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf | |
| 09/20/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf | |
| 11/10/2005 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf | |
| 05/06/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf | |
| 11/20/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf |