Details for New Drug Application (NDA): 204518
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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 204518
Tradename: | PRAMIPEXOLE DIHYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | pramipexole dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204518
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 204518
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204518 | ANDA | Alembic Pharmaceuticals Limited | 46708-574 | 46708-574-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-574-30) |
PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204518 | ANDA | Alembic Pharmaceuticals Limited | 46708-575 | 46708-575-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-575-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.375MG | ||||
Approval Date: | Jan 2, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.75MG | ||||
Approval Date: | Jan 2, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1.5MG | ||||
Approval Date: | Jan 2, 2019 | TE: | AB | RLD: | No |
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