LABELS · 3f1a424d-05a3-40d6-8127-44948e411611

Sandostatin

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: 2026-07-22
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects. ( 1.4 ) 1.1 Acromegaly Sandostatin Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors Sandostatin Injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors Sandostatin Injection is indicated for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tumors. 1.4 Important Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.

Full extracted label fields

application numbers

NDA019667

boxed warning exact

brand names

Sandostatin

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e2c9856-1836-49f0-9472-4dbeeb408f39

generic names

OCTREOTIDE ACETATE

3f1a424d-05a3-40d6-8127-44948e411611

indications and usage exact

1 INDICATIONS AND USAGE Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects. ( 1.4 ) 1.1 Acromegaly Sandostatin Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors Sandostatin Injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors Sandostatin Injection is indicated for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tumors. 1.4 Important Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.

indications and usage tables exact

is original packager

true

manufacturer names

Novartis Pharmaceuticals Corporation

matched search terms

tumor
tumors

package ndcs

0078-0180-61
0078-0180-01
0078-0181-61
0078-0181-01
0078-0182-61
0078-0182-01

product ndcs

0078-0180
0078-0181
0078-0182

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.5 ) 7/2024

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS
SUBCUTANEOUS

rxcuis

207194
207198
207200
312068
312069
312070

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%223f1a424d-05a3-40d6-8127-44948e411611%22

spl effective date

2026-07-22

spl effective time

20260722

spl set id

4e2c9856-1836-49f0-9472-4dbeeb408f39

spl version

substance names

OCTREOTIDE ACETATE

uniis

75R0U2568I

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
NDA019667
payload
all indexed label documents
Appl No
019667
Application Docs Date
2003-01-17 00:00:00
Application Docs ID
11612
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf
Submission No
44
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2008-08-29 00:00:00
Application Docs ID
11613
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf
Submission No
54
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2015-03-12 00:00:00
Application Docs ID
11614
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf
Submission No
62
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2005-09-08 00:00:00
Application Docs ID
33847
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf
Submission No
50
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2010-02-04 00:00:00
Application Docs ID
33848
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf
Submission No
58
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2012-03-27 00:00:00
Application Docs ID
33849
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf
Submission No
61
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2019-04-12 00:00:00
Application Docs ID
58314
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019667s067lbl.pdf
Submission No
67
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2021-06-02 00:00:00
Application Docs ID
67657
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667s070lbl.pdf
Submission No
70
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2021-12-13 00:00:00
Application Docs ID
69537
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667Orig1s071lbl.pdf
Submission No
71
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2022-10-07 00:00:00
Application Docs ID
72272
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019667s073lbl.pdf
Submission No
73
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2023-11-06 00:00:00
Application Docs ID
76389
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf
Submission No
76
Submission Type
SUPPL
Appl No
019667
Application Docs Date
2024-07-15 00:00:00
Application Docs ID
79085
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019667s078lbl.pdf
Submission No
78
Submission Type
SUPPL
all submission records
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
1988-10-21 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
1989-06-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
4
Submission Status
AP
Submission Status Date
1991-06-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
1990-04-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
1991-07-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
1991-10-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
10
Submission Status
AP
Submission Status Date
1992-02-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
11
Submission Status
AP
Submission Status Date
1995-11-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
12
Submission Status
AP
Submission Status Date
1995-10-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
1992-07-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
15
Submission Status
AP
Submission Status Date
1992-09-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019667
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
16
Submission Status
AP
Submission Status Date
1993-01-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA019667
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=019667
has approved submission record
true
latest approved submission date
2024-07-11
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
019667
Application Docs Date
2024-07-15 00:00:00
Application Docs ID
79085
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019667s078lbl.pdf
Submission No
78
Submission Type
SUPPL
official application record
Appl No
019667
Appl Public Notes
Appl Type
NDA
Sponsor Name
NOVARTIS
openfda application present
true
products
Active Ingredient
OCTREOTIDE ACETATE
Appl No
019667
Drug Name
SANDOSTATIN
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 0.05MG BASE/ML
marketing status
Prescription
Active Ingredient
OCTREOTIDE ACETATE
Appl No
019667
Drug Name
SANDOSTATIN
Form
INJECTABLE;INJECTION
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 0.1MG BASE/ML
marketing status
Prescription
Active Ingredient
OCTREOTIDE ACETATE
Appl No
019667
Drug Name
SANDOSTATIN
Form
INJECTABLE;INJECTION
Product No
003
Reference Drug
1
Reference Standard
1
Strength
EQ 0.5MG BASE/ML
marketing status
Prescription
Active Ingredient
OCTREOTIDE ACETATE
Appl No
019667
Drug Name
SANDOSTATIN
Form
INJECTABLE;INJECTION
Product No
004
Reference Drug
1
Reference Standard
0
Strength
EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued
Active Ingredient
OCTREOTIDE ACETATE
Appl No
019667
Drug Name
SANDOSTATIN
Form
INJECTABLE;INJECTION
Product No
005
Reference Drug
1
Reference Standard
0
Strength
EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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

NDA019667

brand names

Sandostatin

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

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exact text: 1 INDICATIONS AND USAGE Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the dis
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extraction review status

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generic names

OCTREOTIDE ACETATE

ind-span-b882803c000295ef4f84

label id

3f1a424d-05a3-40d6-8127-44948e411611

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qualifier mentions

regulatory links

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
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source url

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spl effective date

2026-07-22

spl set id

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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

non_oncology_or_unclear_candidate

Passage 2 · positive indication candidate

application numbers

NDA019667

brand names

Sandostatin

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

end: 783
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exact text: somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs an
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qualifier mentions

context exact
oid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes a
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oid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes ass
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exact text: ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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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 · positive indication candidate

application numbers

NDA019667

brand names

Sandostatin

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

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exact text: ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these tria
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qualifier mentions

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Preserved source evidence · Not medical advice