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LABELS · 2a2ad59f-21cd-4734-9c4b-0154e9db1642

Sandostatin LAR Depot

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
2025-12-22
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal [see Clinical Studies (14), Dosage and Administration (2)] . 1.2 Carcinoid Tumors Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors (VIPomas) Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. 1.4 Important Limitations of Use In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and SANDOSTATIN LAR DEPOT on tumor size, rate of growth and development of metastases, has not been determined.
Full extracted label fields
application numbers
  1. NDA021008
boxed warning exact
    brand names
    1. Sandostatin LAR Depot
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0b7fe9e-7000-4b79-ba3b-291ce92c14f9
    generic names
    1. OCTREOTIDE ACETATE
    id
    2a2ad59f-21cd-4734-9c4b-0154e9db1642
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal [see Clinical Studies (14), Dosage and Administration (2)] . 1.2 Carcinoid Tumors Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors (VIPomas) Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. 1.4 Important Limitations of Use In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and SANDOSTATIN LAR DEPOT on tumor size, rate of growth and development of metastases, has not been determined.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. tumor
      2. tumors
      package ndcs
      1. 0078-0811-81
      2. 0078-0790-61
      3. 0078-0818-81
      4. 0078-0797-61
      5. 0078-0825-81
      6. 0078-0804-61
      product ndcs
      1. 0078-0811
      2. 0078-0818
      3. 0078-0825
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.5 ) 7/2024
      record type
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      routes
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        1. 898589
        2. 898591
        3. 898601
        4. 898603
        5. 898605
        6. 898607
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        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
        results
        limit
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        skip
        100
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2025-12-22
        spl effective time
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        spl version
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        substance names
          uniis
            verification flags
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            Drugs@FDA application source records
            1. application number
              NDA021008
              payload
              all indexed label documents
              1. Appl No
                021008
                Application Docs Date
                1998-11-25 00:00:00
                Application Docs ID
                14153
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              2. Appl No
                021008
                Application Docs Date
                2006-05-16 00:00:00
                Application Docs ID
                14154
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                19
                Submission Type
                SUPPL
              3. Appl No
                021008
                Application Docs Date
                2014-07-22 00:00:00
                Application Docs ID
                14155
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                30
                Submission Type
                SUPPL
              4. Appl No
                021008
                Application Docs Date
                2004-05-03 00:00:00
                Application Docs ID
                35870
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                10
                Submission Type
                SUPPL
              5. Appl No
                021008
                Application Docs Date
                2006-05-16 00:00:00
                Application Docs ID
                35871
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                18
                Submission Type
                SUPPL
              6. Appl No
                021008
                Application Docs Date
                2008-03-05 00:00:00
                Application Docs ID
                35872
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                21
                Submission Type
                SUPPL
              7. Appl No
                021008
                Application Docs Date
                2010-02-04 00:00:00
                Application Docs ID
                35873
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                23
                Submission Type
                SUPPL
              8. Appl No
                021008
                Application Docs Date
                2011-09-30 00:00:00
                Application Docs ID
                35874
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                25
                Submission Type
                SUPPL
              9. Appl No
                021008
                Application Docs Date
                2014-06-02 00:00:00
                Application Docs ID
                35875
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                28
                Submission Type
                SUPPL
              10. Appl No
                021008
                Application Docs Date
                2016-07-25 00:00:00
                Application Docs ID
                35876
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                35
                Submission Type
                SUPPL
              11. Appl No
                021008
                Application Docs Date
                2019-03-27 00:00:00
                Application Docs ID
                57012
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                36
                Submission Type
                SUPPL
              12. Appl No
                021008
                Application Docs Date
                2019-04-12 00:00:00
                Application Docs ID
                58313
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                43
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                021008
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                25
                Submission Status
                AP
                Submission Status Date
                2011-09-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              2. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                27
                Submission Status
                AP
                Submission Status Date
                2012-11-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                021008
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                28
                Submission Status
                AP
                Submission Status Date
                2014-05-19 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                29
                Submission Status
                AP
                Submission Status Date
                2014-01-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                30
                Submission Status
                AP
                Submission Status Date
                2014-07-17 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                32
                Submission Status
                AP
                Submission Status Date
                2014-08-21 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                33
                Submission Status
                AP
                Submission Status Date
                2015-05-18 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                34
                Submission Status
                AP
                Submission Status Date
                2016-05-20 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                021008
                Review Priority
                PRIORITY
                Submission Class Code ID
                4
                Submission No
                35
                Submission Status
                AP
                Submission Status Date
                2016-07-22 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                021008
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                36
                Submission Status
                AP
                Submission Status Date
                2018-12-21 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                021008
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                41
                Submission Status
                AP
                Submission Status Date
                2021-03-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              12. Appl No
                021008
                Review Priority
                901 REQUIRED
                Submission Class Code ID
                3
                Submission No
                43
                Submission Status
                AP
                Submission Status Date
                2019-04-11 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA021008
              approval interpretation
              Application linkage and approved submission are not indication-level current approval verification
              current indication status
              not_reconciled
              has approved submission record
              true
              latest approved submission date
              2024-07-11
              latest label selection rule
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              latest posted label documents
              1. Appl No
                021008
                Application Docs Date
                2024-07-15 00:00:00
                Application Docs ID
                79086
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                49
                Submission Type
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              official application record
              Appl No
              021008
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              NOVARTIS
              openfda application present
              true
              products
              1. Active Ingredient
                OCTREOTIDE ACETATE
                Appl No
                021008
                Drug Name
                SANDOSTATIN LAR
                Form
                INJECTABLE;INJECTION
                Product No
                001
                Reference Drug
                1
                Reference Standard
                0
                Strength
                EQ 10MG BASE/VIAL
                marketing status
                1. Prescription
              2. Active Ingredient
                OCTREOTIDE ACETATE
                Appl No
                021008
                Drug Name
                SANDOSTATIN LAR
                Form
                INJECTABLE;INJECTION
                Product No
                002
                Reference Drug
                1
                Reference Standard
                0
                Strength
                EQ 20MG BASE/VIAL
                marketing status
                1. Prescription
              3. Active Ingredient
                OCTREOTIDE ACETATE
                Appl No
                021008
                Drug Name
                SANDOSTATIN LAR
                Form
                INJECTABLE;INJECTION
                Product No
                003
                Reference Drug
                1
                Reference Standard
                1
                Strength
                EQ 30MG BASE/VIAL
                marketing status
                1. 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
            1. NDA021008
            brand names
            1. Sandostatin LAR Depot
            classification reasons
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            1 INDICATIONS AND USAGE SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe d
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                  1 INDICATIONS AND USAGE SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.
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                  1 INDICATIONS AND USAGE SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. The
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                      SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 )
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