Treats Parkinson’s disease. ANDA 78894, held by Alembic. Pramipexole Dihydrochloride.
As of Nov 15, 2026, ANDA 78894 (Pramipexole Dihydrochloride), held by Alembic, was first approved by FDA on Oct 8, 2010, with 7 approved supplements and 0 published complete response letters.
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of: · Parkinson’s disease (PD) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson’s disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2010 | Original application | Approved | None posted |
| Pramipexole Dihydrochloride0.125MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Pramipexole Dihydrochloride0.25MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Pramipexole Dihydrochloride0.5MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Pramipexole Dihydrochloride1MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Pramipexole Dihydrochloride1.5MG · tablet;oral | Pramipexole Dihydrochloride | Discontinued |
| Feb 28, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 3, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 15, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 15, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 14, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 14, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 14, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 8, 2010 | Original application | Approved | None posted |
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
