LABELS · 43280dcb-52ae-40e4-bd52-723f71f74ab7

Imbruvica

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2025-10-21
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion. 1. 3 Waldenström’s Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1. 4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Full extracted label fields

application numbers

NDA217003
NDA210563
NDA205552

boxed warning exact

brand names

Imbruvica

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44

generic names

IBRUTINIB

43280dcb-52ae-40e4-bd52-723f71f74ab7

indications and usage exact

1 INDICATIONS AND USAGE IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion. 1. 3 Waldenström’s Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1. 4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

indications and usage tables exact

is original packager

true

manufacturer names

Pharmacyclics LLC

matched search terms

lymphoma
leukemia

package ndcs

57962-070-28
57962-140-09
57962-140-12
57962-014-28
57962-280-28
57962-420-28
57962-420-71
57962-007-12

product ndcs

57962-007
57962-070
57962-140
57962-014
57962-280
57962-420

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

1442986
1442992
1994360
1994362
2000017
2000019
2000021
2000023
2000025
2000027
2611536
2611540

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 200
total: 830

terms

https://open.fda.gov/terms/

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2243280dcb-52ae-40e4-bd52-723f71f74ab7%22

spl effective date

2025-10-21

spl effective time

20251021

spl set id

0dfd0279-ff17-4ea9-89be-9803c71bab44

spl version

substance names

IBRUTINIB

uniis

1X70OSD4VX

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA205552
payload
all indexed label documents
Appl No
205552
Application Docs Date
2016-07-18 00:00:00
Application Docs ID
19657
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2013-11-15 00:00:00
Application Docs ID
40475
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
205552
Application Docs Date
2014-07-29 00:00:00
Application Docs ID
40477
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2015-01-29 00:00:00
Application Docs ID
40478
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2016-03-08 00:00:00
Application Docs ID
40479
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2016-05-09 00:00:00
Application Docs ID
40480
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2016-05-09 00:00:00
Application Docs ID
40481
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2014-02-12 00:00:00
Application Docs ID
45438
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf
Submission No
2
Submission Type
ORIG
Appl No
205552
Application Docs Date
2017-04-07 00:00:00
Application Docs ID
47884
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2017-08-02 00:00:00
Application Docs ID
49200
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2017-12-26 00:00:00
Application Docs ID
50854
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf
Submission No
20
Submission Type
SUPPL
Appl No
205552
Application Docs Date
2018-08-28 00:00:00
Application Docs ID
55338
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf
Submission No
25
Submission Type
SUPPL
all submission records
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
44
Submission Status
AP
Submission Status Date
2025-10-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
43
Submission Status
AP
Submission Status Date
2024-12-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
901 REQUIRED
Submission Class Code ID
3
Submission No
42
Submission Status
AP
Submission Status Date
2024-05-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
40
Submission Status
AP
Submission Status Date
2023-05-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
38
Submission Status
AP
Submission Status Date
2022-08-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
37
Submission Status
AP
Submission Status Date
2022-08-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
36
Submission Status
AP
Submission Status Date
2022-08-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
35
Submission Status
AP
Submission Status Date
2022-05-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2020-12-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
32
Submission Status
AP
Submission Status Date
2020-12-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
31
Submission Status
AP
Submission Status Date
2020-08-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205552
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
30
Submission Status
AP
Submission Status Date
2020-04-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA205552
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205552
has approved submission record
true
latest approved submission date
2025-10-21
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
205552
Application Docs Date
2025-10-22 00:00:00
Application Docs ID
83869
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205552s044,210563s020,217003s005lbl.pdf
Submission No
44
Submission Type
SUPPL
official application record
Appl No
205552
Appl Public Notes
Appl Type
NDA
Sponsor Name
PHARMACYCLICS LLC
openfda application present
true
products
Active Ingredient
IBRUTINIB
Appl No
205552
Drug Name
IMBRUVICA
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
140MG
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
205552
Drug Name
IMBRUVICA
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
70MG
marketing status
Prescription
application number
NDA210563
payload
all indexed label documents
Appl No
210563
Application Docs Date
2018-02-21 00:00:00
Application Docs ID
52679
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
210563
Application Docs Date
2018-05-17 00:00:00
Application Docs ID
54222
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf
Submission No
2
Submission Type
ORIG
Appl No
210563
Application Docs Date
2018-08-28 00:00:00
Application Docs ID
55345
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2019-01-29 00:00:00
Application Docs ID
57373
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2019-08-08 00:00:00
Application Docs ID
59631
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2019-11-22 00:00:00
Application Docs ID
61027
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2020-04-21 00:00:00
Application Docs ID
62623
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf
Submission No
6
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2020-08-11 00:00:00
Application Docs ID
64259
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2020-12-22 00:00:00
Application Docs ID
65688
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2020-12-28 00:00:00
Application Docs ID
65749
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2022-05-16 00:00:00
Application Docs ID
71071
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s035,215063s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
210563
Application Docs Date
2022-08-25 00:00:00
Application Docs ID
71893
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s038,210563s014lbl.pdf
Submission No
14
Submission Type
SUPPL
all submission records
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2018-02-16 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
1
Submission Status
AP
Submission Status Date
2018-08-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2018-02-16 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2019-01-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2019-07-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2019-11-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
6
Submission Status
AP
Submission Status Date
2020-04-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2020-08-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
9
Submission Status
AP
Submission Status Date
2020-12-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2020-12-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2022-05-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210563
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
12
Submission Status
AP
Submission Status Date
2022-08-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA210563
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210563
has approved submission record
true
latest approved submission date
2025-10-21
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
210563
Application Docs Date
2025-10-31 00:00:00
Application Docs ID
83994
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205552s044,210563s020,217003s005lbl.pdf
Submission No
20
Submission Type
SUPPL
official application record
Appl No
210563
Appl Public Notes
Appl Type
NDA
Sponsor Name
PHARMACYCLICS LLC
openfda application present
true
products
Active Ingredient
IBRUTINIB
Appl No
210563
Drug Name
IMBRUVICA
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
140MG
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
210563
Drug Name
IMBRUVICA
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
280MG
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
210563
Drug Name
IMBRUVICA
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
1
Strength
420MG
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
210563
Drug Name
IMBRUVICA
Form
TABLET;ORAL
Product No
004
Reference Drug
1
Reference Standard
0
Strength
560MG
marketing status
Discontinued
application number
NDA217003
payload
all indexed label documents
Appl No
217003
Application Docs Date
2022-08-25 00:00:00
Application Docs ID
71891
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/217003s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
217003
Application Docs Date
2024-02-23 00:00:00
Application Docs ID
77610
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217003s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
217003
Application Docs Date
2024-05-14 00:00:00
Application Docs ID
78464
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s042,210563a018,217003s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
217003
Application Docs Date
2024-12-26 00:00:00
Application Docs ID
80732
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s043,210563s019,217003s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
217003
Application Docs Date
2025-10-31 00:00:00
Application Docs ID
83995
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205552s044,210563s020,217003s005lbl.pdf
Submission No
5
Submission Type
SUPPL
all submission records
Appl No
217003
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2025-10-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217003
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2024-12-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217003
Review Priority
901 REQUIRED
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2024-05-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217003
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2024-02-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
217003
Review Priority
PRIORITY
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2022-08-24 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA217003
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
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has approved submission record
true
latest approved submission date
2025-10-21
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
217003
Application Docs Date
2025-10-31 00:00:00
Application Docs ID
83995
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205552s044,210563s020,217003s005lbl.pdf
Submission No
5
Submission Type
SUPPL
official application record
Appl No
217003
Appl Public Notes
Appl Type
NDA
Sponsor Name
PHARMACYCLICS LLC
openfda application present
true
products
Active Ingredient
IBRUTINIB
Appl No
217003
Drug Name
IMBRUVICA
Form
SUSPENSION;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
70MG/ML
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
217003
Drug Name
IMBRUVICA
Form
CAPSULE;ORAL
Product No
002
Reference Drug
0
Reference Standard
0
Strength
70MG
marketing status
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Active Ingredient
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Appl No
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Drug Name
IMBRUVICA
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Product No
003
Reference Drug
0
Reference Standard
0
Strength
140MG
marketing status
Prescription
Active Ingredient
IBRUTINIB
Appl No
217003
Drug Name
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Product No
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Reference Drug
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Reference Standard
0
Strength
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marketing status
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Active Ingredient
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Appl No
217003
Drug Name
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Product No
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Reference Drug
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Reference Standard
0
Strength
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marketing status
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Active Ingredient
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Appl No
217003
Drug Name
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Reference Standard
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217003
Drug Name
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Form
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Product No
007
Reference Drug
0
Reference Standard
0
Strength
560MG
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

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NDA210563
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brand names

Imbruvica

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use intent

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Passage 2 · positive indication candidate

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use intent

tumor_directed_candidate

Passage 3 · positive indication candidate

application numbers

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brand names

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classification reasons

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use intent

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Passage 4 · positive indication candidate

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brand names

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exact text: oma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 C
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use intent

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exact text: tröm’s macroglobulinemia (WM) ( 1.3 ). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ). 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion. 1. 3 Waldenström’s Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1. 4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
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1182
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indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic ther
kind
age
polarity
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exact text
age 1 year and older with chronic graft-versus-host disease
label id
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source field
indications_and_usage_exact
source text sha256
d5a57a173dd27efe18e4d94f01250b226040245b11d33df1dff6e2566caa598c
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1201

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1324
end exclusive: true
exact text: 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion. 1. 3 Waldenström’s Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1. 4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
label id: 43280dcb-52ae-40e4-bd52-723f71f74ab7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d5a57a173dd27efe18e4d94f01250b226040245b11d33df1dff6e2566caa598c
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2243280dcb-52ae-40e4-bd52-723f71f74ab7%22

spl effective date

2025-10-21

spl set id

0dfd0279-ff17-4ea9-89be-9803c71bab44

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Preserved source evidence · Not medical advice