LABELS · 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

GALLIUM CITRATE GA-67

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: 2025-08-13
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

Full extracted label fields

application numbers

NDA018058

boxed warning exact

brand names

GALLIUM CITRATE GA-67

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f670c12-cca5-4d73-8a88-241f753d1bc7

generic names

GALLIUM CITRATE GA-67

3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

indications and usage exact

INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

indications and usage tables exact

is original packager

true

manufacturer names

Curium US LLC

matched search terms

carcinoma
lymphoma

package ndcs

69945-180-06
69945-180-12

product ndcs

69945-180

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

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%223c4363ac-ad4f-f5fc-e063-6294a90a1ec2%22

spl effective date

2025-08-13

spl effective time

20250813

spl set id

5f670c12-cca5-4d73-8a88-241f753d1bc7

spl version

substance names

GALLIUM CHLORIDE GA-67

uniis

A04B19O2B0

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
NDA018058
payload
all indexed label documents
all submission records
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
13
Submission Status
AP
Submission Status Date
2014-03-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
10
Submission Status
AP
Submission Status Date
1985-11-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
1982-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
1982-09-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
1984-03-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
1982-05-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
1981-12-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
2
Submission Status
AP
Submission Status Date
1980-07-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
1980-07-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018058
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
1979-02-01 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA018058
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=018058
has approved submission record
true
latest approved submission date
2014-03-19
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
official application record
Appl No
018058
Appl Public Notes
Appl Type
NDA
Sponsor Name
CURIUM
openfda application present
true
products
Active Ingredient
GALLIUM CITRATE GA-67
Appl No
018058
Drug Name
GALLIUM CITRATE GA 67
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
0
Reference Standard
0
Strength
2mCi/ML
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 · unclassified context

application numbers

NDA018058

brand names

GALLIUM CITRATE GA-67

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 366
end exclusive: true
exact text: INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting s
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 0

current approval status

not_reconciled

duplicate text group

dup-5bff54e9f3f9ca89d141

extraction review status

automated_candidate_pending_source_review

generic names

GALLIUM CITRATE GA-67

ind-span-3f9583f852977d8fc94f

label id

3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 166
end exclusive: true
exact text: INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma.
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%223c4363ac-ad4f-f5fc-e063-6294a90a1ec2%22

spl effective date

2025-08-13

spl set id

5f670c12-cca5-4d73-8a88-241f753d1bc7

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 2 · unclassified context

application numbers

NDA018058

brand names

GALLIUM CITRATE GA-67

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 397
end exclusive: true
exact text: INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 0

current approval status

not_reconciled

duplicate text group

dup-4a7e5910f89a45488035

extraction review status

automated_candidate_pending_source_review

generic names

GALLIUM CITRATE GA-67

ind-span-18b8a9e3f6092fafd4fe

label id

3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 295
end exclusive: true
exact text: Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 167

source url

https://api.fda.gov/drug/label.json?search=id%3A%223c4363ac-ad4f-f5fc-e063-6294a90a1ec2%22

spl effective date

2025-08-13

spl set id

5f670c12-cca5-4d73-8a88-241f753d1bc7

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 · unclassified context

application numbers

NDA018058

brand names

GALLIUM CITRATE GA-67

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 397
end exclusive: true
exact text: and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 96

current approval status

not_reconciled

duplicate text group

dup-adf44bb1326ea8aa440f

extraction review status

automated_candidate_pending_source_review

generic names

GALLIUM CITRATE GA-67

ind-span-4b7bf9293e9b10e5e8ad

label id

3c4363ac-ad4f-f5fc-e063-6294a90a1ec2

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 397
end exclusive: true
exact text: Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
label id: 3c4363ac-ad4f-f5fc-e063-6294a90a1ec2
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8032e92bef8b3dd85402a5b059fbd62fa9554060cfe5a918f0b056afe37a8431
start: 296

source url

https://api.fda.gov/drug/label.json?search=id%3A%223c4363ac-ad4f-f5fc-e063-6294a90a1ec2%22

spl effective date

2025-08-13

spl set id

5f670c12-cca5-4d73-8a88-241f753d1bc7

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