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Approved Drug Products containing 210563 listed in the FDA Orange Book. Original Data : FDA Website

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01 PHARMACYCLICS LLC (4)

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01 TABLET;ORAL (4)

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01 DISCN (1)

02 RX (3)

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01 IMBRUVICA (4)

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01 Yes (4)

URL Supplier Web Content
TABLET; ORAL
560MG
2018-02-16
210563
IMBRUVICA
DISCN
Yes
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Swiss Biotech Day

Not Confirmed

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URL Supplier Web Content
TABLET; ORAL
280MG
2018-02-16
210563
IMBRUVICA
RX
Yes
Abbvie company banner

Swiss Biotech Day

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
420MG
2018-02-16
210563
IMBRUVICA
RX
Yes
Abbvie company banner

Swiss Biotech Day

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET; ORAL
140MG
2018-02-16
210563
IMBRUVICA
RX
Yes
Abbvie company banner

Swiss Biotech Day

Not Confirmed

envelop Contact Supplier

Looking for FDA Orange Book APPLICATION 210563

Looking for FDA Orange Book APPLICATION 210563 4

19

Pharmacyclics, based in U.S.A, is a pharmaceutical company.

One of their notable products is IBRUTINIB, with a corresponding application number 210563.

Regulatory Information DISCN

With a dosage strength 560MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2018-02-16

18

Pharmacyclics, based in U.S.A, is a pharmaceutical company.

One of their notable products is IBRUTINIB, with a corresponding application number 210563.

Regulatory Information RX

With a dosage strength 280MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2018-02-16

17

Pharmacyclics, based in U.S.A, is a pharmaceutical company.

One of their notable products is IBRUTINIB, with a corresponding application number 210563.

Regulatory Information RX

With a dosage strength 420MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2018-02-16

16

Pharmacyclics, based in U.S.A, is a pharmaceutical company.

One of their notable products is IBRUTINIB, with a corresponding application number 210563.

Regulatory Information RX

With a dosage strength 140MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2018-02-16

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