Details for New Drug Application (NDA): 203615
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The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
Summary for 203615
Tradename: | PRAMIPEXOLE DIHYDROCHLORIDE |
Applicant: | Actavis Elizabeth |
Ingredient: | pramipexole dihydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.25MG | ||||
Approval Date: | Oct 14, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 3.75MG | ||||
Approval Date: | Jan 3, 2017 | TE: | AB | RLD: | No |
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