LABELS · ddc155a1-509c-4d7e-bab1-fa5891ef354e

decitabine

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: 2020-07-23
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)

Full extracted label fields

application numbers

NDA205582

boxed warning exact

brand names

decitabine

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c155d6ba-9a16-406c-919e-65a149689ab9

generic names

DECITABINE

ddc155a1-509c-4d7e-bab1-fa5891ef354e

indications and usage exact

1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)

indications and usage tables exact

is original packager

true

manufacturer names

Sun Pharmaceutical Industries, Inc.

matched search terms

leukemia
myelodysplastic

package ndcs

47335-361-41
47335-362-40

product ndcs

47335-361

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

rxcuis

636631

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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: 700
total: 830

terms

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

sha256

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url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ddc155a1-509c-4d7e-bab1-fa5891ef354e%22

spl effective date

2020-07-23

spl effective time

20200723

spl set id

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spl version

substance names

uniis

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
NDA205582
payload
all indexed label documents
Appl No
205582
Application Docs Date
2014-01-28 00:00:00
Application Docs ID
19660
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205582s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
205582
Application Docs Date
2019-05-23 00:00:00
Application Docs ID
58843
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205582s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
205582
Application Docs Date
2020-02-04 00:00:00
Application Docs ID
61773
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
205582
Application Docs Date
2020-05-22 00:00:00
Application Docs ID
63262
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
205582
Application Docs Date
2020-09-21 00:00:00
Application Docs ID
64619
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
Submission No
15
Submission Type
SUPPL
all submission records
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2014-01-23 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
2014-08-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
2016-03-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2019-05-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2020-02-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2020-05-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205582
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2020-09-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA205582
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=205582
has approved submission record
true
latest approved submission date
2020-09-16
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
205582
Application Docs Date
2020-09-21 00:00:00
Application Docs ID
64619
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205582s015lbl.pdf
Submission No
15
Submission Type
SUPPL
official application record
Appl No
205582
Appl Public Notes
Appl Type
NDA
Sponsor Name
SUN PHARM
openfda application present
true
products
Active Ingredient
DECITABINE
Appl No
205582
Drug Name
DECITABINE
Form
POWDER;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
0
Strength
50MG/VIAL
marketing status
Discontinued

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

NDA205582

brand names

decitabine

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

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content role

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exact text: 1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and sec
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qualifier mentions

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context exact
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kind
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exact text
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exact text: 1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
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source url

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spl effective date

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use intent

supportive_care_candidate

Passage 2 · positive indication candidate

application numbers

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brand names

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classification reasons

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exact text: blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
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use intent

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Passage 3 · unclassified context

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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2f2b1d9771afbee074cf186515dfca335fb7bb045407882cfa47310c794776b7
start: 1078

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ddc155a1-509c-4d7e-bab1-fa5891ef354e%22

spl effective date

2020-07-23

spl set id

c155d6ba-9a16-406c-919e-65a149689ab9

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

Preserved source evidence · Not medical advice