Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021225
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRENA | LEVONORGESTREL | 52MG | SYSTEM;INTRAUTERINE | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/12/2022 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021225s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021225Orig1s043ltr.pdf | |
| 08/11/2021 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021225Orig1s042ltr.pdf | |
| 05/26/2021 | SUPPL-41 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021225Orig1s041ltr.pdf |
| 08/20/2020 | SUPPL-40 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021225Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021225Orig1s040ltr.pdf | |
| 05/25/2017 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1S039ltr.pdf | |
| 06/08/2017 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1s038ltr.pdf | |
| 12/21/2016 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021225s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/21225Orig1s037ltr.pdf | |
| 06/08/2021 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021225Orig1s036ltr.pdf | |
| 12/08/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2014 | SUPPL-33 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021225Orig1s033.pdf | |
| 08/07/2013 | SUPPL-32 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021225Orig1s032_correctionltr.pdf | |
| 10/22/2015 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021225Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021225Orig1s031.pdf | |
| 03/07/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/2009 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021225s027ltr.pdf | |
| 07/21/2008 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s019ltr.pdf | |
| 06/02/2008 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s018ltr.pdf |
| 05/28/2008 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s017ltr.pdf |
| 08/27/2003 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21225sce010ltr.pdf |
| 01/08/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21225slr009ltr.pdf |
| 11/27/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/29/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/12/2022 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021225s043lbl.pdf | |
| 08/11/2021 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s042lbl.pdf | |
| 06/08/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s036lbl.pdf | |
| 08/20/2020 | SUPPL-40 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021225Orig1s040lbl.pdf | |
| 06/08/2017 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s038lbl.pdf | |
| 05/25/2017 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s039lbl.pdf | |
| 12/21/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021225s037lbl.pdf | |
| 10/22/2015 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf | |
| 05/29/2014 | SUPPL-33 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf |
| 08/07/2013 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf | |
| 10/01/2009 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf | |
| 07/21/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf |