Details for New Drug Application (NDA): 020272
NDA 020272 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 020272
| Tradename: | RISPERDAL |
| Applicant: | Janssen Pharms |
| Ingredient: | risperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020272
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | risperidone | TABLET;ORAL | 020272 | NDA | Janssen Pharmaceuticals, Inc. | 50458-300 | 50458-300-01 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-300-01) / 10 TABLET in 1 BLISTER PACK |
| RISPERDAL | risperidone | TABLET;ORAL | 020272 | NDA | Janssen Pharmaceuticals, Inc. | 50458-300 | 50458-300-06 | 60 TABLET in 1 BOTTLE (50458-300-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 29, 1993 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 29, 1993 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Dec 29, 1993 | TE: | AB | RLD: | Yes | ||||
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