LABELS · e545c060-c1c8-43af-b77e-7e951af59e1d

JELMYTO

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: 2025-07-09
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )

Full extracted label fields

application numbers

NDA211728

boxed warning exact

brand names

JELMYTO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e

generic names

MITOMYCIN

e545c060-c1c8-43af-b77e-7e951af59e1d

indications and usage exact

1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

UroGen Pharma, Inc.

matched search terms

cancer

package ndcs

72493-103-03
72493-101-40
72493-102-20

product ndcs

72493-103

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

rxcuis

2375818
2375823

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

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e545c060-c1c8-43af-b77e-7e951af59e1d%22

spl effective date

2025-07-09

spl effective time

20250709

spl set id

3d3d5053-5427-4a68-a40b-edb60699521e

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

Drugs@FDA application source records

application number
NDA211728
payload
all indexed label documents
Appl No
211728
Application Docs Date
2020-04-15 00:00:00
Application Docs ID
62580
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211728s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
211728
Application Docs Date
2021-01-15 00:00:00
Application Docs ID
65911
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211728s002lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
211728
Application Docs Date
2024-05-15 00:00:00
Application Docs ID
78476
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728Orig1s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
211728
Application Docs Date
2024-10-07 00:00:00
Application Docs ID
79829
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728s010lbl.pdf
Submission No
10
Submission Type
SUPPL
all submission records
Appl No
211728
Review Priority
PRIORITY
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2020-04-15 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
211728
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2021-01-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211728
Review Priority
N/A
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
2022-09-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211728
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2024-10-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA211728
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=211728
has approved submission record
true
latest approved submission date
2024-10-04
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
211728
Application Docs Date
2024-10-07 00:00:00
Application Docs ID
79829
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211728s010lbl.pdf
Submission No
10
Submission Type
SUPPL
official application record
Appl No
211728
Appl Public Notes
Appl Type
NDA
Sponsor Name
UROGEN PHARMA
openfda application present
true
products
Active Ingredient
MITOMYCIN
Appl No
211728
Drug Name
JELMYTO
Form
POWDER;PYELOCALYCEAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
40MG/VIAL
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

NDA211728

brand names

JELMYTO

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: 276
end exclusive: true
exact text: 1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 0

current approval status

not_reconciled

duplicate text group

dup-7d3e63d69dce695887b5

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-cbdd0a47db9dafc8354a

label id

e545c060-c1c8-43af-b77e-7e951af59e1d

positive predicate support span

end: 46
end exclusive: true
exact text: is indicated
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 34

qualifier mentions

context exact
TIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
kind
age
polarity
not_inferred
span
end
82
end exclusive
true
exact text
adult patients
label id
e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start
68

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 138
end exclusive: true
exact text: 1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e545c060-c1c8-43af-b77e-7e951af59e1d%22

spl effective date

2025-07-09

spl set id

3d3d5053-5427-4a68-a40b-edb60699521e

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 · positive indication candidate

application numbers

NDA211728

brand names

JELMYTO

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: 276
end exclusive: true
exact text: 1 INDICATIONS AND USAGE JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 0

current approval status

not_reconciled

duplicate text group

dup-ca7d1f2521e4664848b8

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-84c9dd6956ba2097ca34

label id

e545c060-c1c8-43af-b77e-7e951af59e1d

positive predicate support span

end: 178
end exclusive: true
exact text: is an alkylating drug indicated
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 147

qualifier mentions

context exact
ELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
kind
age
polarity
not_inferred
span
end
214
end exclusive
true
exact text
adult patients
label id
e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start
200
context exact
JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Can
kind
biomarker
polarity
not_inferred
span
end
196
end exclusive
true
exact text
alkylating drug indicated for the treatment
label id
e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start
153

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 270
end exclusive: true
exact text: JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 139

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e545c060-c1c8-43af-b77e-7e951af59e1d%22

spl effective date

2025-07-09

spl set id

3d3d5053-5427-4a68-a40b-edb60699521e

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 3 · unclassified context

application numbers

NDA211728

brand names

JELMYTO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 276
end exclusive: true
exact text: lt patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 71

current approval status

not_reconciled

duplicate text group

dup-e487e08f7ca7a7b27517

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-8ed7279836e42ee3c779

label id

e545c060-c1c8-43af-b77e-7e951af59e1d

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 276
end exclusive: true
exact text: ( 1 )
label id: e545c060-c1c8-43af-b77e-7e951af59e1d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5fe18b59829d98dfb979b4cb99dd8ae4956a877005ea296348cc8bf07199423
start: 271

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e545c060-c1c8-43af-b77e-7e951af59e1d%22

spl effective date

2025-07-09

spl set id

3d3d5053-5427-4a68-a40b-edb60699521e

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