Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209721

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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
100MG;150MG
Marketing Status: Prescription

Active Ingredient: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG;150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209721
Product Number: 001
Approval Date: Aug 22, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
133MG;200MG
Marketing Status: Prescription

Active Ingredient: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 133MG;200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209721
Product Number: 002
Approval Date: Aug 22, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
167MG;250MG
Marketing Status: Prescription

Active Ingredient: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 167MG;250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209721
Product Number: 003
Approval Date: Aug 22, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
200MG;300MG
Marketing Status: Prescription

Active Ingredient: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209721
Product Number: 004
Approval Date: Aug 22, 2018
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information