Details for New Drug Application (NDA): 020272
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NDA 020272 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from three suppliers. Additional details are available on the RISPERDAL profile page.
The generic ingredient in RISPERDAL is risperidone. There are thirty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in RISPERDAL is risperidone. There are thirty drug master file entries for this compound. Thirty-nine 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 | ||||
Expired US Patents for NDA 020272
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-002 | Dec 29, 1993 | 5,158,952*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-008 | May 10, 1999 | 4,804,663*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-001 | Dec 29, 1993 | 4,804,663*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-005 | Dec 29, 1993 | 5,158,952*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-001 | Dec 29, 1993 | 5,158,952*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-004 | Dec 29, 1993 | 5,158,952*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-002 | Dec 29, 1993 | 4,804,663*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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