Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021356

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VIREAD (TENOFOVIR DISOPROXIL FUMARATE)
150MG
Marketing Status: Prescription

Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: VIREAD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021356
Product Number: 002
Approval Date: Jan 18, 2012
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIREAD (TENOFOVIR DISOPROXIL FUMARATE)
200MG
Marketing Status: Prescription

Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: VIREAD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021356
Product Number: 003
Approval Date: Jan 18, 2012
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIREAD (TENOFOVIR DISOPROXIL FUMARATE)
250MG
Marketing Status: Prescription

Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: VIREAD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021356
Product Number: 004
Approval Date: Jan 18, 2012
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIREAD (TENOFOVIR DISOPROXIL FUMARATE)
300MG
Marketing Status: Prescription

Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: VIREAD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021356
Product Number: 001
Approval Date: Oct 26, 2001
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information