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01 5VERTEX PHARMS INC

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
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IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG;200MG

Approval Date : 2015-07-02

Application Number : 206038

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG;100MG

Approval Date : 2016-09-28

Application Number : 206038

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 125MG/PACKET;100MG/PACKET

Approval Date : 2018-08-07

Application Number : 211358

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 188MG/PACKET;150MG/PACKET

Approval Date : 2018-08-07

Application Number : 211358

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

IVACAFTOR; LUMACAFTOR

Brand Name : ORKAMBI

Dosage Form : GRANULE;ORAL

Dosage Strength : 94MG/PACKET;75MG/PACKET

Approval Date : 2022-09-02

Application Number : 211358

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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