Details for New Drug Application (NDA): 079229
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The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 079229
Tradename: | ROPINIROLE HYDROCHLORIDE |
Applicant: | Orbion Pharms |
Ingredient: | ropinirole hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079229
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 079229
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079229 | ANDA | Bionpharma Inc. | 69452-356 | 69452-356-20 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-356-20) |
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079229 | ANDA | Bionpharma Inc. | 69452-357 | 69452-357-20 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-357-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.25MG BASE | ||||
Approval Date: | Nov 28, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Nov 28, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Nov 28, 2012 | TE: | AB | RLD: | No |
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