Details for New Drug Application (NDA): 201576
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NDA 201576 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-five 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-five 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-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 201576
| Tradename: | ROPINIROLE HYDROCHLORIDE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | ropinirole hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 201576
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 201576
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201576 | ANDA | Dr. Reddys Laboratories Limited | 55111-659 | 55111-659-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-05) |
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201576 | ANDA | Dr. Reddys Laboratories Limited | 55111-659 | 55111-659-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-30) |
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 002
| 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 003
| 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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