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01 1ACTAVIS LABS FL INC

02 4AMNEAL EU LTD

03 2ANNORA PHARMA

04 4HETERO LABS LTD V

05 7NOVARTIS

06 4TEVA PHARMS INC

07 3TEVA PHARMS USA INC

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
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ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG

Brand Name : ELTROMBOPAG

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG

Approval Date :

Application Number : 206788

RX/OTC/DISCN :

RLD :

TE Code :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG ACID

Approval Date : 2008-11-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG ACID

Approval Date : 2008-11-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG ACID

Approval Date : 2009-09-08

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 12.5MG ACID

Approval Date : 2011-10-20

Application Number : 22291

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2012-11-16

Application Number : 22291

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

ELTROMBOPAG OLAMINE

Brand Name : PROMACTA KIT

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : EQ 25MG ACID/PACKET

Approval Date : 2015-08-24

Application Number : 207027

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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