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Approved Drug Products containing Entrectinib listed in the FDA Orange Book. Original Data : FDA Website

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01 5GENENTECH INC

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PharmaCompass

01

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2019-08-15

Application Number : 212725

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2019-08-15

Application Number : 212725

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Luxepack
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Luxepack
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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date :

Application Number : 212726

RX/OTC/DISCN :

RLD :

TE Code :

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04

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date :

Application Number : 212726

RX/OTC/DISCN :

RLD :

TE Code :

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05

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ENTRECTINIB

Brand Name : ROZLYTREK

Dosage Form : PELLETS;ORAL

Dosage Strength : 50MG/PACKET

Approval Date : 2023-10-20

Application Number : 218550

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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