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01 4ALKEM LABS LTD

02 1CIPLA LTD

03 4MACLEODS PHARMACEUTICALS LTD

04 2MSN LABORATORIES PRIVATE LTD

05 4PRINSTON PHARMA INC

06 4TAKEDA PHARMS USA

07 3ZYDUS PHARMS

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 211089

RX/OTC/DISCN :

RLD :

TE Code :

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 211085

RX/OTC/DISCN :

RLD :

TE Code :

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 211024

RX/OTC/DISCN :

RLD :

TE Code :

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 211024

RX/OTC/DISCN :

RLD :

TE Code :

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date :

Application Number : 211024

RX/OTC/DISCN :

RLD :

TE Code :

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE

Brand Name : VORTIOXETINE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date :

Application Number : 211024

RX/OTC/DISCN :

RLD :

TE Code :

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE HYDROBROMIDE

Brand Name : TRINTELLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2013-09-30

Application Number : 204447

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE HYDROBROMIDE

Brand Name : TRINTELLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2013-09-30

Application Number : 204447

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE HYDROBROMIDE

Brand Name : TRINTELLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2013-09-30

Application Number : 204447

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

VORTIOXETINE HYDROBROMIDE

Brand Name : TRINTELLIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2013-09-30

Application Number : 204447

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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