Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020667
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.25MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/01/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Letter (PDF)
Review Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667.cfm https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/020667Orig1s000_LBL.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020667Orig1s044ltr.pdf | |
| 04/03/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020667Orig1s041ltr.pdf | |
| 01/30/2020 | SUPPL-39 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020667Orig1s039ltr.pdf | |
| 05/10/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020667s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf | |
| 07/28/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s034ltr.pdf | |
| 01/14/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s033ltr.pdf | |
| 11/20/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2015 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf | |
| 03/01/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020667Orig1s029ltr.pdf | |
| 08/31/2012 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s027ltr.pdf | |
| 05/13/2011 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020667s025ltr.pdf | |
| 07/17/2012 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf | |
| 07/17/2012 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf | |
| 07/17/2012 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf | |
| 07/17/2012 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf | |
| 07/17/2012 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf | |
| 12/31/2008 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf | |
| 12/31/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf | |
| 12/31/2008 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf | |
| 11/07/2006 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf | |
| 11/07/2006 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf | |
| 12/04/2002 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/06/2003 | SUPPL-8 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20667slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020667_S008_MirapexTOC.cfm |
| 09/03/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/18/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf | |
| 04/03/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667s041lbl.pdf | |
| 01/30/2020 | SUPPL-39 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf | |
| 01/30/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf | |
| 05/10/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020667s036lbl.pdf | |
| 07/28/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf | |
| 01/14/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf | |
| 03/27/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf | |
| 03/27/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf | |
| 03/01/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf | |
| 08/31/2012 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf | |
| 07/17/2012 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf | |
| 07/17/2012 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf | |
| 07/17/2012 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf | |
| 07/17/2012 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf | |
| 07/17/2012 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf | |
| 05/13/2011 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf | |
| 12/31/2008 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf | |
| 12/31/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf | |
| 12/31/2008 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf | |
| 11/07/2006 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf | |
| 11/07/2006 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf |