LABELS · 5437ba4d-fe9b-4dde-b9b9-97a1389fd682

ZUSDURI

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: 2025-06-20
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )

Full extracted label fields

application numbers

NDA215793

boxed warning exact

brand names

ZUSDURI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8dc68793-bca8-4e3d-b672-622961b58255

generic names

MITOMYCIN

5437ba4d-fe9b-4dde-b9b9-97a1389fd682

indications and usage exact

1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

UroGen Pharma, Inc

matched search terms

cancer

package ndcs

72493-106-03
72493-104-40
72493-105-60

product ndcs

72493-106

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

rxcuis

2719766
2719771

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.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: 300
total: 830

terms

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

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%225437ba4d-fe9b-4dde-b9b9-97a1389fd682%22

spl effective date

2025-06-20

spl effective time

20250620

spl set id

8dc68793-bca8-4e3d-b672-622961b58255

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
NDA215793
payload
all indexed label documents
Appl No
215793
Application Docs Date
2025-06-13 00:00:00
Application Docs ID
82567
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215793s000lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
215793
Review Priority
STANDARD
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2025-06-12 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA215793
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=215793
has approved submission record
true
latest approved submission date
2025-06-12
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
215793
Application Docs Date
2025-06-13 00:00:00
Application Docs ID
82567
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215793s000lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
215793
Appl Public Notes
Appl Type
NDA
Sponsor Name
UROGEN PHARMA
openfda application present
true
products
Active Ingredient
MITOMYCIN
Appl No
215793
Drug Name
ZUSDURI
Form
POWDER;INTRAVESICAL
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

NDA215793

brand names

ZUSDURI

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: 349
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 0

current approval status

not_reconciled

duplicate text group

dup-0c5d6b28be884dc5474e

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-340d626d927d8059d776

label id

5437ba4d-fe9b-4dde-b9b9-97a1389fd682

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 33

qualifier mentions

context exact
ATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invas
kind
age
polarity
not_inferred
span
end
81
end exclusive
true
exact text
adult patients
label id
5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start
67
context exact
DURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
kind
stage_or_setting
polarity
not_inferred
span
end
131
end exclusive
true
exact text
recurrent low-grade intermediate-risk non-mu
label id
5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start
87

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 174
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%225437ba4d-fe9b-4dde-b9b9-97a1389fd682%22

spl effective date

2025-06-20

spl set id

8dc68793-bca8-4e3d-b672-622961b58255

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

NDA215793

brand names

ZUSDURI

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: 349
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 0

current approval status

not_reconciled

duplicate text group

dup-d1313a7078fee159d5ba

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-b3f48dcc23f5803502ec

label id

5437ba4d-fe9b-4dde-b9b9-97a1389fd682

positive predicate support span

end: 214
end exclusive: true
exact text: is an alkylating drug indicated
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 183

qualifier mentions

context exact
USDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invas
kind
age
polarity
not_inferred
span
end
250
end exclusive
true
exact text
adult patients
label id
5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start
236
context exact
ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-ris
kind
biomarker
polarity
not_inferred
span
end
232
end exclusive
true
exact text
alkylating drug indicated for the treatment
label id
5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start
189
context exact
ing drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
kind
stage_or_setting
polarity
not_inferred
span
end
300
end exclusive
true
exact text
recurrent low-grade intermediate-risk non-mu
label id
5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start
256

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 343
end exclusive: true
exact text: ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 175

source url

https://api.fda.gov/drug/label.json?search=id%3A%225437ba4d-fe9b-4dde-b9b9-97a1389fd682%22

spl effective date

2025-06-20

spl set id

8dc68793-bca8-4e3d-b672-622961b58255

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

NDA215793

brand names

ZUSDURI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 349
end exclusive: true
exact text: bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 144

current approval status

not_reconciled

duplicate text group

dup-9a55f49f3d5ed53cc239

extraction review status

automated_candidate_pending_source_review

generic names

MITOMYCIN

ind-span-1391057e4d386fc549f1

label id

5437ba4d-fe9b-4dde-b9b9-97a1389fd682

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 349
end exclusive: true
exact text: ( 1 )
label id: 5437ba4d-fe9b-4dde-b9b9-97a1389fd682
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 08737982ab61b7f132f67e47010e77d8f0eaf275a988be205cfe3cfbe8c11fea
start: 344

source url

https://api.fda.gov/drug/label.json?search=id%3A%225437ba4d-fe9b-4dde-b9b9-97a1389fd682%22

spl effective date

2025-06-20

spl set id

8dc68793-bca8-4e3d-b672-622961b58255

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