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LABELS · 22078227-b702-2e8c-e063-6294a90aeb67

Kit for the Prepartion of Technetium Tc99m Sulfur Colloid

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
2024-09-13
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 Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
Full extracted label fields
application numbers
  1. NDA017858
boxed warning exact
    brand names
    1. Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeaf70fd-46bd-4fec-ba9d-2366fdf07888
    generic names
    1. TECHNETIUM TC 99M SULFUR COLLOID
    id
    22078227-b702-2e8c-e063-6294a90aeb67
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sun Pharmaceutical Industries, Inc.
      matched search terms
      1. cancer
      2. melanoma
      3. tumor
      4. malignant
      package ndcs
      1. 45567-0030-1
      product ndcs
      1. 45567-0030
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
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        routes
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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
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            source url
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            spl effective date
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            substance names
              uniis
                verification flags
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                Drugs@FDA application source records
                1. application number
                  NDA017858
                  payload
                  all indexed label documents
                  1. Appl No
                    017858
                    Application Docs Date
                    2011-07-27 00:00:00
                    Application Docs ID
                    11080
                    Application Docs Title
                    0
                    Application Docs Type ID
                    2
                    Submission No
                    34
                    Submission Type
                    SUPPL
                  2. Appl No
                    017858
                    Application Docs Date
                    2012-08-15 00:00:00
                    Application Docs ID
                    11081
                    Application Docs Title
                    0
                    Application Docs Type ID
                    2
                    Submission No
                    35
                    Submission Type
                    SUPPL
                  3. Appl No
                    017858
                    Application Docs Date
                    2019-12-20 00:00:00
                    Application Docs ID
                    61366
                    Application Docs Title
                    0
                    Application Docs Type ID
                    2
                    Submission No
                    49
                    Submission Type
                    SUPPL
                  all submission records
                  1. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    3
                    Submission No
                    49
                    Submission Status
                    AP
                    Submission Status Date
                    2019-12-19 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  2. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    45
                    Submission Status
                    AP
                    Submission Status Date
                    2015-12-04 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  3. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    44
                    Submission Status
                    AP
                    Submission Status Date
                    2015-09-28 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  4. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    43
                    Submission Status
                    AP
                    Submission Status Date
                    2015-09-22 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  5. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    42
                    Submission Status
                    AP
                    Submission Status Date
                    2015-08-13 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  6. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    40
                    Submission Status
                    AP
                    Submission Status Date
                    2016-04-22 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  7. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    39
                    Submission Status
                    AP
                    Submission Status Date
                    2014-09-12 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  8. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    38
                    Submission Status
                    AP
                    Submission Status Date
                    2013-12-04 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  9. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    4
                    Submission No
                    37
                    Submission Status
                    AP
                    Submission Status Date
                    2012-12-14 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  10. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    2
                    Submission No
                    35
                    Submission Status
                    AP
                    Submission Status Date
                    2012-08-13 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  11. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    2
                    Submission No
                    34
                    Submission Status
                    AP
                    Submission Status Date
                    2011-07-22 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  12. Appl No
                    017858
                    Review Priority
                    STANDARD
                    Submission Class Code ID
                    3
                    Submission No
                    24
                    Submission Status
                    AP
                    Submission Status Date
                    2002-09-13 00:00:00
                    Submission Type
                    SUPPL
                    Submissions Public Notes
                  application number
                  NDA017858
                  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
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                  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
                  1. Appl No
                    017858
                    Application Docs Date
                    2019-12-20 00:00:00
                    Application Docs ID
                    61366
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                    0
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                  official application record
                  Appl No
                  017858
                  Appl Public Notes
                  Appl Type
                  NDA
                  Sponsor Name
                  SUN PHARM INDS INC
                  openfda application present
                  true
                  products
                  1. Active Ingredient
                    TECHNETIUM TC-99M SULFUR COLLOID KIT
                    Appl No
                    017858
                    Drug Name
                    AN-SULFUR COLLOID
                    Form
                    SOLUTION;INJECTION, ORAL
                    Product No
                    001
                    Reference Drug
                    1
                    Reference Standard
                    1
                    Strength
                    N/A
                    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
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                1. Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
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                1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and det
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                    1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency.
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                    alization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast
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                        s of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and dete
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                            Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1) : In adults, to assist in the: localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults.
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                            of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
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                                In adults and pediatric patients, for: imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
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                                Preserved source evidence · Not medical advice