Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022187

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INTELENCE (ETRAVIRINE)
25MG
Marketing Status: Prescription

Active Ingredient: ETRAVIRINE
Proprietary Name: INTELENCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022187
Product Number: 003
Approval Date: Mar 26, 2012
Applicant Holder Full Name: JANSSEN RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

INTELENCE (ETRAVIRINE)
100MG
Marketing Status: Prescription

Active Ingredient: ETRAVIRINE
Proprietary Name: INTELENCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022187
Product Number: 001
Approval Date: Jan 18, 2008
Applicant Holder Full Name: JANSSEN RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

INTELENCE (ETRAVIRINE)
200MG
Marketing Status: Prescription

Active Ingredient: ETRAVIRINE
Proprietary Name: INTELENCE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022187
Product Number: 002
Approval Date: Dec 22, 2010
Applicant Holder Full Name: JANSSEN RESEARCH AND DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information