NDA 20667, held by Boehringer Ingelheim. Pramipexole Dihydrochloride.
As of Nov 13, 2026, NDA 20667 (Mirapex), held by Boehringer Ingelheim, was first approved by FDA on Jul 1, 1997, with 30 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2012 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| May 13, 2011 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 2006 | Supplement 13Efficacy (new indication or use) | Approved | |
| Nov 7, 2006 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 1, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mirapex0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Mirapex0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Mirapex1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Mirapex1.25MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Mirapex1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Mirapex0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Mirapex0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pramipexole Dihydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2021 | Supplement 44Labeling · Standard review | Approved | |
| Apr 3, 2020 | Supplement 41Labeling | Approved | |
| Jan 30, 2020 | Supplement 39Labeling · Standard review | Approved | |
| May 10, 2018 | Supplement 36Labeling · Standard review | Approved | |
| Jul 28, 2016 | Supplement 34Labeling · Standard review | Approved | |
| Jan 14, 2016 | Supplement 33Labeling · Standard review | Approved | |
| Nov 20, 2015 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| May 11, 2015 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2015 | Supplement 30Labeling · Standard review | Approved | |
| Mar 1, 2013 | Supplement 29Labeling · Standard review | Approved | |
| Aug 31, 2012 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 23Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 21Labeling · Standard review | Approved | |
| Jul 17, 2012 | Supplement 19Labeling · Standard review | Approved | |
| May 13, 2011 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Dec 31, 2008 | Supplement 18Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 17Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Nov 7, 2006 | Supplement 13Efficacy (new indication or use) | Approved | |
| Nov 7, 2006 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2003 | Supplement 8Labeling · Standard review | Approved | |
| Dec 4, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1999 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 19, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 12, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1997 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1997 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
