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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021976

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PREZISTA (DARUNAVIR)
75MG
Marketing Status: Prescription
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021976
Product Number: 004
Approval Date: Dec 18, 2008
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
PREZISTA (DARUNAVIR)
150MG
Marketing Status: Prescription
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021976
Product Number: 005
Approval Date: Dec 18, 2008
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
PREZISTA (DARUNAVIR)
600MG
Marketing Status: Prescription
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021976
Product Number: 002
Approval Date: Feb 25, 2008
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
PREZISTA (DARUNAVIR)
800MG
Marketing Status: Prescription
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021976
Product Number: 006
Approval Date: Nov 9, 2012
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
PREZISTA (DARUNAVIR)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021976
Product Number: 001
Approval Date: Jun 23, 2006
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
PREZISTA (DARUNAVIR)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021976
Product Number: 003
Approval Date: Oct 21, 2008
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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