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Approved Drug Products containing 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine listed in the FDA Orange Book. Original Data : FDA Website

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG;300MG

Approval Date : 2021-01-13

Application Number : 91055

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

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EMTRICITABINE

Brand Name : EMTRICITABINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2023-03-15

Application Number : 79188

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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EMTRICITABINE

Brand Name : EMTRIVA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2003-07-02

Application Number : 21500

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : TRUVADA

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG;300MG

Approval Date : 2004-08-02

Application Number : 21752

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : TRUVADA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG;150MG

Approval Date : 2016-03-10

Application Number : 21752

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : TRUVADA

Dosage Form : TABLET;ORAL

Dosage Strength : 133MG;200MG

Approval Date : 2016-03-10

Application Number : 21752

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : TRUVADA

Dosage Form : TABLET;ORAL

Dosage Strength : 167MG;250MG

Approval Date : 2016-03-10

Application Number : 21752

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

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EMTRICITABINE

Brand Name : EMTRIVA

Dosage Form : SOLUTION;ORAL

Dosage Strength : 10MG/ML

Approval Date : 2005-09-28

Application Number : 21896

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

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EMTRICITABINE

Brand Name : EMTRIVA

Dosage Form : SOLUTION; ORAL

Dosage Strength : 10MG/ML

Approval Date :

Application Number : 21896

RX/OTC/DISCN :

RLD :

TE Code :

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10

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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand Name : EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Dosage Form : TABLET; ORAL

Dosage Strength : 200MG; 300MG

Approval Date :

Application Number : 90049

RX/OTC/DISCN :

RLD :

TE Code :

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