Details for New Drug Application (NDA): 207011
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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 207011
Tradename: | PRAMIPEXOLE DIHYDROCHLORIDE |
Applicant: | Unichem |
Ingredient: | pramipexole dihydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207011
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 207011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 207011 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-207 | 29300-207-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-207-10) |
PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 207011 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-207 | 29300-207-16 | 60 TABLET in 1 BOTTLE, PLASTIC (29300-207-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.125MG | ||||
Approval Date: | Dec 19, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Dec 19, 2018 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Dec 19, 2018 | TE: | RLD: | No |
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