Details for New Drug Application (NDA): 090869
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The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 090869
Tradename: | ROPINIROLE HYDROCHLORIDE |
Applicant: | Actavis Elizabeth |
Ingredient: | ropinirole hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090869
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 090869
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090869 | ANDA | Actavis Pharma, Inc. | 0228-3640 | 0228-3640-03 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3640-03) |
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090869 | ANDA | Actavis Pharma, Inc. | 0228-3658 | 0228-3658-03 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | May 17, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | May 17, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | May 17, 2012 | TE: | AB | RLD: | No |
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