Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021187
Company: ORGANON USA ORGANON
Company: ORGANON USA ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUVARING | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/03/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21187ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-40 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021187s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021187Orig1s040ltr.pdf | |
| 05/08/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021187s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021187Orig1s037ltr.pdf | |
| 12/04/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187s036ltr.pdf | |
| 12/04/2018 | SUPPL-35 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187s035ltr.pdf | |
| 12/04/2017 | SUPPL-34 | Labeling-Container/Carton Labels |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021187Orig1s034.pdf |
| 08/09/2017 | SUPPL-32 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s032ltr.pdf | |
| 02/12/2018 | SUPPL-31 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187Orig1s031ltr.pdf | |
| 05/30/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s028ltr.pdf | |
| 09/30/2016 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021187Orig1s027ltr.pdf | |
| 10/31/2014 | SUPPL-25 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s025ltr.pdf | |
| 06/18/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s024ltr.pdf | |
| 07/19/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf | |
| 10/04/2013 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf | |
| 02/19/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2008 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021187s018ltr.pdf |
| 10/02/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021187s017ltr.pdf | |
| 12/12/2006 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/29/2005 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021187s012ltr.pdf | |
| 03/02/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr008ltr.pdf |
| 02/04/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr007ltr.pdf |
| 11/05/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2002 | 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 |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-40 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021187s040lbl.pdf | |
| 04/29/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021187s040lbl.pdf | |
| 05/08/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021187s037lbl.pdf | |
| 12/04/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s036lbl.pdf | |
| 12/04/2018 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf | |
| 12/04/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf | |
| 02/12/2018 | SUPPL-31 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf | |
| 02/12/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf | |
| 08/09/2017 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf | |
| 08/09/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf | |
| 05/30/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s028lbl.pdf | |
| 09/30/2016 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf | |
| 10/31/2014 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf | |
| 06/18/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf | |
| 10/04/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf | |
| 10/04/2013 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf | |
| 10/02/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf | |
| 07/29/2005 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf | |
| 10/03/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf |
NUVARING
RING;VAGINAL; 0.015MG/24HR;0.12MG/24HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ELURYNG | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 210830 | AMNEAL |
| ENILLORING | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 211157 | XIROMED |
| ETHINYL ESTRADIOL; ETONOGESTREL | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 204305 | TEVA PHARMS USA INC |
| HALOETTE | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | No | AB | 211328 | DR REDDYS LABS SA |
| NUVARING | ETHINYL ESTRADIOL; ETONOGESTREL | 0.015MG/24HR;0.12MG/24HR | RING;VAGINAL | Prescription | Yes | AB | 021187 | ORGANON USA ORGANON |