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01 1LUPIN LTD

02 1VERTEX PHARMS

03 16VERTEX PHARMS INC

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PharmaCompass

01

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Approval Date : 2012-01-31

Application Number : 203188

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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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03

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
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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04

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : GRANULE;ORAL

Dosage Strength : 50MG/PACKET

Approval Date : 2015-03-17

Application Number : 207925

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : GRANULE;ORAL

Dosage Strength : 75MG/PACKET

Approval Date : 2015-03-17

Application Number : 207925

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : GRANULE;ORAL

Dosage Strength : 25MG/PACKET

Approval Date : 2019-04-29

Application Number : 207925

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : GRANULE;ORAL

Dosage Strength : 5.8MG/PACKET

Approval Date : 2023-05-03

Application Number : 207925

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR

Brand Name : KALYDECO

Dosage Form : GRANULE;ORAL

Dosage Strength : 13.4MG/PACKET

Approval Date : 2023-05-03

Application Number : 207925

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR; IVACAFTOR, TEZACAFTOR

Brand Name : SYMDEKO (COPACKAGED)

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG;150MG, 100MG

Approval Date : 2018-02-12

Application Number : 210491

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

IVACAFTOR; IVACAFTOR, TEZACAFTOR

Brand Name : SYMDEKO (COPACKAGED)

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG;75MG, 50MG

Approval Date : 2019-06-21

Application Number : 210491

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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