Details for New Drug Application (NDA): 201047
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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 201047
Tradename: | ROPINIROLE HYDROCHLORIDE |
Applicant: | Sandoz Inc |
Ingredient: | ropinirole hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201047
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 201047
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201047 | ANDA | Sandoz Inc | 0781-5780 | 0781-5780-31 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-31) |
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201047 | ANDA | Sandoz Inc | 0781-5780 | 0781-5780-92 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-92) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Jun 6, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jun 6, 2012 | TE: | AB | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Jun 6, 2012 | TE: | AB | RLD: | No |
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