Details for New Drug Application (NDA): 020588
NDA 020588 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from two suppliers. Additional details are available on the RISPERDAL profile page.
The generic ingredient in RISPERDAL is risperidone. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in RISPERDAL is risperidone. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 020588
| Tradename: | RISPERDAL |
| Applicant: | Janssen Pharms |
| Ingredient: | risperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020588
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | risperidone | SOLUTION;ORAL | 020588 | NDA | Janssen Pharmaceuticals, Inc. | 50458-305 | 50458-305-03 | 30 mL in 1 BOTTLE (50458-305-03) |
| RISPERDAL | risperidone | SOLUTION;ORAL | 020588 | NDA | Janssen Pharmaceuticals, Inc. | 50458-596 | 50458-596-01 | 30 mL in 1 BOTTLE (50458-596-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Jun 10, 1996 | TE: | AA | RLD: | Yes | ||||
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