Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 957499a8-90f5-4cbd-916d-abfd8251e1b4

GLEOLAN

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
2026-01-29
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 )
Full extracted label fields
application numbers
  1. NDA208630
boxed warning exact
    brand names
    1. GLEOLAN
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdeded66-0017-42cf-9471-13f231014323
    generic names
    1. AMINOLEVULINIC ACID HYDROCHLORIDE
    id
    957499a8-90f5-4cbd-916d-abfd8251e1b4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. NX DEVELOPMENT CORP
      matched search terms
      1. malignant
      2. glioma
      package ndcs
      1. 71469-231-01
      product ndcs
      1. 71469-231
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00500.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
          results
          limit
          100
          skip
          500
          total
          830
          sha256
          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
          url
          https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22957499a8-90f5-4cbd-916d-abfd8251e1b4%22
          spl effective date
          2026-01-29
          spl effective time
          20260129
          spl set id
          cdeded66-0017-42cf-9471-13f231014323
          spl version
          8
          substance names
          1. AMINOLEVULINIC ACID HYDROCHLORIDE
          uniis
          1. V35KBM8JGR
          verification flags
          1. oncology_keyword_candidate_not_clinically_classified
          2. spl_text_not_verified_identical_to_latest_approved_label
          3. individual_indications_not_split_or_reconciled
          Drugs@FDA application source records
          1. application number
            NDA208630
            payload
            all indexed label documents
            1. Appl No
              208630
              Application Docs Date
              2017-06-07 00:00:00
              Application Docs ID
              48662
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              208630
              Application Docs Date
              2018-06-21 00:00:00
              Application Docs ID
              54663
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              2
              Submission Type
              SUPPL
            3. Appl No
              208630
              Application Docs Date
              2018-08-23 00:00:00
              Application Docs ID
              55277
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              3
              Submission Type
              SUPPL
            4. Appl No
              208630
              Application Docs Date
              2024-04-24 00:00:00
              Application Docs ID
              78233
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              7
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              208630
              Review Priority
              PRIORITY
              Submission Class Code ID
              12
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2017-06-06 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              208630
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2018-06-12 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              208630
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              2018-08-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              208630
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              2019-03-19 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              208630
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              2024-04-23 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA208630
            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
            2024-04-23
            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
              208630
              Application Docs Date
              2024-04-24 00:00:00
              Application Docs ID
              78233
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              7
              Submission Type
              SUPPL
            official application record
            Appl No
            208630
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            NXDC
            openfda application present
            true
            products
            1. Active Ingredient
              AMINOLEVULINIC ACID HYDROCHLORIDE
              Appl No
              208630
              Drug Name
              GLEOLAN
              Form
              FOR SOLUTION;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              1.5GM/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. NDA208630
          brand names
          1. GLEOLAN
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          425
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant t
          label id
          957499a8-90f5-4cbd-916d-abfd8251e1b4
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-c44b0e38dd41840d2de7
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. AMINOLEVULINIC ACID HYDROCHLORIDE
          id
          ind-span-4d2dfcc0009636f532d8
          label id
          957499a8-90f5-4cbd-916d-abfd8251e1b4
          positive predicate support span
          end
          44
          end exclusive
          true
          exact text
          is indicated
          label id
          957499a8-90f5-4cbd-916d-abfd8251e1b4
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
          start
          32
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
              source defined aliases
                source span
                end
                225
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.
                label id
                957499a8-90f5-4cbd-916d-abfd8251e1b4
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22957499a8-90f5-4cbd-916d-abfd8251e1b4%22
                spl effective date
                2026-01-29
                spl set id
                cdeded66-0017-42cf-9471-13f231014323
                spl version
                8
                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
                diagnostic_candidate
                Passage 2 · positive indication candidate
                application numbers
                1. NDA208630
                brand names
                1. GLEOLAN
                classification reasons
                1. explicit_positive_indication_predicate
                2. diagnostic_use_words
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                452
                end exclusive
                true
                exact text
                eolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 )
                label id
                957499a8-90f5-4cbd-916d-abfd8251e1b4
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                start
                26
                current approval status
                not_reconciled
                duplicate text group
                dup-ca5b61a1679e2478d9ad
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. AMINOLEVULINIC ACID HYDROCHLORIDE
                id
                ind-span-65cb0f9a5d99ae9eca8c
                label id
                957499a8-90f5-4cbd-916d-abfd8251e1b4
                positive predicate support span
                end
                271
                end exclusive
                true
                exact text
                is an optical imaging agent indicated
                label id
                957499a8-90f5-4cbd-916d-abfd8251e1b4
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                start
                234
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                    source defined aliases
                      source span
                      end
                      446
                      end exclusive
                      true
                      exact text
                      Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
                      label id
                      957499a8-90f5-4cbd-916d-abfd8251e1b4
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                      start
                      226
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22957499a8-90f5-4cbd-916d-abfd8251e1b4%22
                      spl effective date
                      2026-01-29
                      spl set id
                      cdeded66-0017-42cf-9471-13f231014323
                      spl version
                      8
                      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
                      diagnostic_candidate
                      Passage 3 · unclassified context
                      application numbers
                      1. NDA208630
                      brand names
                      1. GLEOLAN
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      452
                      end exclusive
                      true
                      exact text
                      imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 )
                      label id
                      957499a8-90f5-4cbd-916d-abfd8251e1b4
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                      start
                      247
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-a24dac82ff1076ba50cf
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. AMINOLEVULINIC ACID HYDROCHLORIDE
                      id
                      ind-span-654e3efb9793af5d6278
                      label id
                      957499a8-90f5-4cbd-916d-abfd8251e1b4
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                          source defined aliases
                            source span
                            end
                            452
                            end exclusive
                            true
                            exact text
                            ( 1 )
                            label id
                            957499a8-90f5-4cbd-916d-abfd8251e1b4
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            88d4d98e1f9990db80b141d8f340a9fca55aad01a07003f7acb1ba314153c3b5
                            start
                            447
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22957499a8-90f5-4cbd-916d-abfd8251e1b4%22
                            spl effective date
                            2026-01-29
                            spl set id
                            cdeded66-0017-42cf-9471-13f231014323
                            spl version
                            8
                            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