• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

  • Print
  • Share
  • E-mail
-

Search results from the "OB_Rx" table for query on "022264."



Active Ingredient: PALIPERIDONE PALMITATE
Dosage Form;Route: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Proprietary Name: INVEGA SUSTENNA
Applicant: JANSSEN PHARMS
Strength: 39MG/0.25ML (39MG/0.25ML)
Application Number: N022264
Product Number: 001
Approval Date: Jul 31, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE PALMITATE
Dosage Form;Route: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Proprietary Name: INVEGA SUSTENNA
Applicant: JANSSEN PHARMS
Strength: 78MG/0.5ML (78MG/0.5ML)
Application Number: N022264
Product Number: 002
Approval Date: Jul 31, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE PALMITATE
Dosage Form;Route: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Proprietary Name: INVEGA SUSTENNA
Applicant: JANSSEN PHARMS
Strength: 117MG/0.75ML (117MG/0.75ML)
Application Number: N022264
Product Number: 003
Approval Date: Jul 31, 2009
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE PALMITATE
Dosage Form;Route: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Proprietary Name: INVEGA SUSTENNA
Applicant: JANSSEN PHARMS
Strength: 156MG/ML (156MG/ML)
Application Number: N022264
Product Number: 004
Approval Date: Jul 31, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE PALMITATE
Dosage Form;Route: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Proprietary Name: INVEGA SUSTENNA
Applicant: JANSSEN PHARMS
Strength: 234MG/1.5ML (156MG/ML)
Application Number: N022264
Product Number: 005
Approval Date: Jul 31, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Return to Electronic Orange Book Home Page


FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2014
Patent and Generic Drug Product Data Last Updated July 22, 2014

-
-