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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 021444


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NDA 021444 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from six suppliers. There is one patent 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 021444
Tradename:RISPERDAL
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021444
Medical Subject Heading (MeSH) Categories for 021444
Paragraph IV (Patent) Challenges for 021444
Tradename Dosage Ingredient NDA Submissiondate
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-04-11
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-03-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-004 Dec 23, 2004   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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