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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 "022187."



Active Ingredient: ETRAVIRINE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: INTELENCE
Applicant: JANSSEN R AND D
Strength: 100MG
Application Number: N022187
Product Number: 001
Approval Date: Jan 18, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: ETRAVIRINE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: INTELENCE
Applicant: JANSSEN R AND D
Strength: 200MG
Application Number: N022187
Product Number: 002
Approval Date: Dec 22, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: ETRAVIRINE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: INTELENCE
Applicant: JANSSEN R AND D
Strength: 25MG
Application Number: N022187
Product Number: 003
Approval Date: Mar 26, 2012
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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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