Details for New Drug Application (NDA): 020588
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The generic ingredient in RISPERDAL is risperidone. There are thirty drug master file entries for this compound. Thirty-eight 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 Pharmaceutical, 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 |
Expired US Patents for NDA 020588
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | RISPERDAL | risperidone | SOLUTION;ORAL | 020588-001 | Jun 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RISPERDAL | risperidone | SOLUTION;ORAL | 020588-001 | Jun 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RISPERDAL | risperidone | SOLUTION;ORAL | 020588-001 | Jun 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RISPERDAL | risperidone | SOLUTION;ORAL | 020588-001 | Jun 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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