Details for New Drug Application (NDA): 204413
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NDA 204413 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys Labs Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Norvium Bioscience, Orbion Pharms, and Zydus Lifesciences, and is included in twenty NDAs. It is available from twenty-four suppliers. Additional details are available on the ROPINIROLE HYDROCHLORIDE profile page.
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.
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 204413
| Tradename: | ROPINIROLE HYDROCHLORIDE |
| Applicant: | Prinston Inc |
| Ingredient: | ropinirole hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204413
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 204413
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204413 | ANDA | Solco Healthcare US, LLC | 43547-554 | 43547-554-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03) |
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204413 | ANDA | Solco Healthcare US, LLC | 43547-554 | 43547-554-09 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | May 11, 2022 | 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 11, 2022 | 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 11, 2022 | TE: | AB | RLD: | No | ||||
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