LABELS · 19048218-75dd-45fc-8e6e-fc660d861fb7

Dasatinib

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: 2024-07-09
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)

Full extracted label fields

application numbers

NDA021986

boxed warning exact

brand names

Dasatinib

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1931e73f-918c-4d69-9543-de9643513d05

generic names

DASATINIB

19048218-75dd-45fc-8e6e-fc660d861fb7

indications and usage exact

1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)

indications and usage tables exact

is original packager

true

manufacturer names

Prasco Laboratories

matched search terms

leukemia

package ndcs

66993-233-60
66993-234-60
66993-235-60
66993-236-30
66993-237-30
66993-238-30

product ndcs

66993-233
66993-234
66993-235
66993-236
66993-237
66993-238

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

643105
643107
643109
799047
1045402
1045406

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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: 0
total: 830

terms

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

sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2219048218-75dd-45fc-8e6e-fc660d861fb7%22

spl effective date

2024-07-09

spl effective time

20240709

spl set id

1931e73f-918c-4d69-9543-de9643513d05

spl version

substance names

DASATINIB

uniis

RBZ1571X5H

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
NDA021986
payload
all indexed label documents
Appl No
021986
Application Docs Date
2006-07-03 00:00:00
Application Docs ID
16693
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021986
Application Docs Date
2009-05-25 00:00:00
Application Docs ID
16694
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2010-10-28 00:00:00
Application Docs ID
16695
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2011-10-12 00:00:00
Application Docs ID
16696
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2015-08-13 00:00:00
Application Docs ID
16697
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf
Submission No
16
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2007-11-13 00:00:00
Application Docs ID
37998
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2010-07-31 00:00:00
Application Docs ID
37999
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2010-10-28 00:00:00
Application Docs ID
38000
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2011-10-12 00:00:00
Application Docs ID
38001
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2013-06-17 00:00:00
Application Docs ID
38002
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2014-05-12 00:00:00
Application Docs ID
38003
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
021986
Application Docs Date
2015-08-13 00:00:00
Application Docs ID
38004
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf
Submission No
17
Submission Type
SUPPL
all submission records
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
28
Submission Status
AP
Submission Status Date
2024-07-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
27
Submission Status
AP
Submission Status Date
2023-02-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
25
Submission Status
AP
Submission Status Date
2021-06-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
23
Submission Status
AP
Submission Status Date
2018-11-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
21
Submission Status
AP
Submission Status Date
2018-12-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
20
Submission Status
AP
Submission Status Date
2017-11-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2017-08-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
18
Submission Status
AP
Submission Status Date
2016-09-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2015-08-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
16
Submission Status
AP
Submission Status Date
2015-08-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
15
Submission Status
AP
Submission Status Date
2015-01-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021986
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2014-04-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021986
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=021986
has approved submission record
true
latest approved submission date
2024-07-31
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
021986
Application Docs Date
2024-08-02 00:00:00
Application Docs ID
79280
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021986s028lbl.pdf
Submission No
28
Submission Type
SUPPL
official application record
Appl No
021986
Appl Public Notes
Appl Type
NDA
Sponsor Name
BRISTOL MYERS SQUIBB
openfda application present
true
products
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
20MG
marketing status
Prescription
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
50MG
marketing status
Prescription
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
70MG
marketing status
Prescription
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
004
Reference Drug
1
Reference Standard
1
Strength
100MG
marketing status
Prescription
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
005
Reference Drug
1
Reference Standard
0
Strength
80MG
marketing status
Prescription
Active Ingredient
DASATINIB
Appl No
021986
Drug Name
SPRYCEL
Form
TABLET;ORAL
Product No
006
Reference Drug
1
Reference Standard
0
Strength
140MG
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

NDA021986

brand names

Dasatinib

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 533
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 0

current approval status

not_reconciled

duplicate text group

dup-53c71d60049ca212c50f

extraction review status

automated_candidate_pending_source_review

generic names

DASATINIB

ind-span-e45efba6c78fad49d164

label id

19048218-75dd-45fc-8e6e-fc660d861fb7

positive predicate support span

end: 55
end exclusive: true
exact text: are indicated
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 42

qualifier mentions

context exact
USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+)
kind
age
polarity
not_inferred
span
end
91
end exclusive
true
exact text
adult patients
label id
19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start
77

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 333
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2219048218-75dd-45fc-8e6e-fc660d861fb7%22

spl effective date

2024-07-09

spl set id

1931e73f-918c-4d69-9543-de9643513d05

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

Passage 2 · unclassified context

application numbers

NDA021986

brand names

Dasatinib

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 654
end exclusive: true
exact text: me-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tabl
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 134

current approval status

not_reconciled

duplicate text group

dup-4112ecdf51e03a06c7be

extraction review status

automated_candidate_pending_source_review

generic names

DASATINIB

ind-span-6e2276130c081c2ebb63

label id

19048218-75dd-45fc-8e6e-fc660d861fb7

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 454
end exclusive: true
exact text: Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 334

source url

https://api.fda.gov/drug/label.json?search=id%3A%2219048218-75dd-45fc-8e6e-fc660d861fb7%22

spl effective date

2024-07-09

spl set id

1931e73f-918c-4d69-9543-de9643513d05

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

unclear

Passage 3 · positive indication candidate

application numbers

NDA021986

brand names

Dasatinib

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 839
end exclusive: true
exact text: se Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) ad
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 255

current approval status

not_reconciled

duplicate text group

dup-70ff9f02b2577cd3de2f

extraction review status

automated_candidate_pending_source_review

generic names

DASATINIB

ind-span-97e956de12b5dafe1d57

label id

19048218-75dd-45fc-8e6e-fc660d861fb7

positive predicate support span

end: 486
end exclusive: true
exact text: are indicated
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 473

qualifier mentions

context exact
Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newl
kind
age
polarity
not_inferred
span
end
526
end exclusive
true
exact text
pediatric patients
label id
19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit
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source array index
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source field
indications_and_usage_exact
source text sha256
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start
508
context exact
lder with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
kind
regimen
polarity
not_inferred
span
end
638
end exclusive
true
exact text
in combination with chemotherapy
label id
19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit
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source array index
0
source field
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source text sha256
6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start
606

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 639
end exclusive: true
exact text: Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
label id: 19048218-75dd-45fc-8e6e-fc660d861fb7
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 6c4af41504846e949556a1466f20dcee6c15f243c4753923e2ad5a708da3ff55
start: 455

source url

https://api.fda.gov/drug/label.json?search=id%3A%2219048218-75dd-45fc-8e6e-fc660d861fb7%22

spl effective date

2024-07-09

spl set id

1931e73f-918c-4d69-9543-de9643513d05

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

Passage 4 · positive indication candidate

application numbers

NDA021986

brand names

Dasatinib

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

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Preserved source evidence · Not medical advice