Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021529
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMPLANON | ETONOGESTREL | 68MG/IMPLANT | IMPLANT;IMPLANTATION | Discontinued | None | No | No |
| NEXPLANON | ETONOGESTREL | 68MG/IMPLANT | IMPLANT;IMPLANTATION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/17/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021529_implanon_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/29/2023 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf | |
| 09/29/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf | |
| 09/29/2023 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf | |
| 09/24/2020 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021529s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021529Orig1s019,s020ltr.pdf | |
| 09/24/2020 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021529Orig1s019,s020ltr.pdf |
| 04/22/2019 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021529Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s018.pdf | |
| 05/19/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021529Orig1s015ltr.pdf | |
| 03/14/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf | |
| 09/03/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/2015 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021529Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s011.pdf | |
| 09/27/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf | |
| 06/12/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s008.pdf | |
| 05/13/2011 | SUPPL-7 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021529s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021529Orig1s007.pdf | |
| 02/01/2012 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021529s006ltr.pdf | |
| 02/19/2009 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021529s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s004.pdf | |
| 01/18/2007 | SUPPL-1 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021529s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/29/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/29/2023 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/29/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/29/2023 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/29/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/29/2023 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf | |
| 09/24/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021529s019s020lbl.pdf | |
| 04/22/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf | |
| 05/19/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf | |
| 03/14/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf | |
| 08/19/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf | |
| 07/03/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf | |
| 09/27/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf | |
| 02/01/2012 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf | |
| 05/13/2011 | SUPPL-7 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf | |
| 02/19/2009 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf | |
| 07/17/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf |