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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 seven suppliers. There are eight 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 twenty-nine drug master file entries for this compound. Sixty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the risperidone profile page.

Summary for NDA: 021444

Tradename:
RISPERDAL
Applicant:
Janssen Pharms
Ingredient:
risperidone
Patents:1
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021444

Suppliers and Packaging for NDA: 021444

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL 021444 NDA Janssen Pharmaceuticals, Inc. 50458-315 50458-315-28 7 BLISTER PACK in 1 BOX (50458-315-28) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL 021444 NDA Janssen Pharmaceuticals, Inc. 50458-315 50458-315-30 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50458-315-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Apr 2, 2003TE:ABRLD:No
Patent:6,224,905*PEDPatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes
Patent:6,224,905*PEDPatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Apr 2, 2003TE:ABRLD:No
Patent:6,224,905*PEDPatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-001Apr 2, 20034,804,663*PED► subscribe
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-003Apr 2, 20034,804,663*PED► subscribe
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-005Dec 23, 20045,648,093*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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