Treats Parkinson's disease (PD). ANDA 213444, held by Novast Labs. Pramipexole Dihydrochloride.
As of Nov 15, 2026, ANDA 213444 (Pramipexole Dihydrochloride), held by Novast Labs, was first approved by FDA on Feb 3, 2022, with 1 approved supplement and 0 published complete response letters.
Pramipexole dihydrochloride extended- release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2022 | Original application | Approved | None posted |
| Pramipexole Dihydrochloride0.375MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride0.75MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride1.5MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride2.25MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride3MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride3.75MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Pramipexole Dihydrochloride4.5MG · tablet, extended release;oral | Pramipexole Dihydrochloride | Rx |
| Oct 25, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 3, 2022 | 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
