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Generated: November 15, 2018

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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 seven suppliers. There are four patents protecting this drug and two Paragraph IV challenges. 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. Fifty-seven 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
Formulation / Manufacturing:see details
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 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
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Colorcon

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