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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021999."



Active Ingredient: PALIPERIDONE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INVEGA
Applicant: JANSSEN PHARMS
Strength: 3MG
Application Number: N021999
Product Number: 001
Approval Date: Dec 19, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INVEGA
Applicant: JANSSEN PHARMS
Strength: 6MG
Application Number: N021999
Product Number: 002
Approval Date: Dec 19, 2006
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INVEGA
Applicant: JANSSEN PHARMS
Strength: 9MG
Application Number: N021999
Product Number: 003
Approval Date: Dec 19, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: PALIPERIDONE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INVEGA
Applicant: JANSSEN PHARMS
Strength: 1.5MG
Application Number: N021999
Product Number: 006
Approval Date: Aug 26, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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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 August 2014
Patent and Generic Drug Product Data Last Updated September 29, 2014

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