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Generated: November 19, 2018

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Details for New Drug Application (NDA): 021346

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NDA 021346 describes RISPERDAL CONSTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the RISPERDAL CONSTA profile page.

The generic ingredient in RISPERDAL CONSTA 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 021346
Tradename:RISPERDAL CONSTA
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021346
Suppliers and Packaging for NDA: 021346
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-306 50458-306-11 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-307 50458-307-11 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength25MG/VIAL
Approval Date:Oct 29, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 30, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 30, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 30, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021346

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Colorcon
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