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 | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.25MG | TABLET;ORAL | Discontinued | None | No | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Discontinued | None | Yes | No |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf | |
| 01/30/2020 | SUPPL-39 | Labeling-Container/Carton Labels | 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 |
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