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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020588


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NDA 020588 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from four 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-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
Pharmacology for NDA: 020588
Medical Subject Heading (MeSH) Categories for 020588
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:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Jun 10, 1996TE:AARLD: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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