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

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Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 140MG

Approval Date : 2013-11-13

Application Number : 205552

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

02

PHARMACYCLICS LLC

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Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 70MG

Approval Date : 2017-12-20

Application Number : 205552

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

03

PHARMACYCLICS LLC

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Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : TABLET;ORAL

Dosage Strength : 140MG

Approval Date : 2018-02-16

Application Number : 210563

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

04

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : TABLET;ORAL

Dosage Strength : 280MG

Approval Date : 2018-02-16

Application Number : 210563

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

05

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : TABLET;ORAL

Dosage Strength : 420MG

Approval Date : 2018-02-16

Application Number : 210563

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

06

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : TABLET;ORAL

Dosage Strength : 560MG

Approval Date : 2018-02-16

Application Number : 210563

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

07

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD : Yes

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 70MG/ML

Approval Date : 2022-08-24

Application Number : 217003

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

08

PHARMACYCLICS LLC

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Luxepack

Not Confirmed

U.S.A

RLD :

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 70MG

Approval Date :

Application Number : 217003

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

09

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD :

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 140MG

Approval Date :

Application Number : 217003

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

10

PHARMACYCLICS LLC

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Luxepack

Not Confirmed

U.S.A

RLD :

TE Code :

IBRUTINIB

Brand Name : IMBRUVICA

Dosage Form : TABLET;ORAL

Dosage Strength : 140MG

Approval Date :

Application Number : 217003

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link