Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021976

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PREZISTA (DARUNAVIR ETHANOLATE)
EQ 75MG BASE Marketing Status: Prescription

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG BASE
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 ETHANOLATE)
EQ 150MG BASE Marketing Status: Prescription

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
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 ETHANOLATE)
EQ 600MG BASE Marketing Status: Prescription

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 600MG BASE
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 ETHANOLATE)
EQ 800MG BASE Marketing Status: Prescription

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 800MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
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 ETHANOLATE)
EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy 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 ETHANOLATE)
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy 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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