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LABELS · 942707af-a16c-4a62-b733-103e0fac915e

VALCHLOR

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
2024-11-20
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 VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
Full extracted label fields
application numbers
  1. NDA202317
boxed warning exact
    brand names
    1. VALCHLOR
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
    generic names
    1. MECHLORETHAMINE HYDROCHLORIDE
    id
    942707af-a16c-4a62-b733-103e0fac915e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Helsinn Therapeutics (U.S.), Inc.
      matched search terms
      1. lymphoma
      package ndcs
      1. 69639-120-01
      product ndcs
      1. 69639-120
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. TOPICAL
        rxcuis
        1. 1437711
        2. 1437713
        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%22942707af-a16c-4a62-b733-103e0fac915e%22
        spl effective date
        2024-11-20
        spl effective time
        20241120
        spl set id
        6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
        spl version
        12
        substance names
        1. MECHLORETHAMINE
        uniis
        1. 50D9XSG0VR
        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
          NDA202317
          payload
          all indexed label documents
          1. Appl No
            202317
            Application Docs Date
            2013-08-27 00:00:00
            Application Docs ID
            40165
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            202317
            Application Docs Date
            2015-11-04 00:00:00
            Application Docs ID
            40166
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            202317
            Application Docs Date
            2020-02-06 00:00:00
            Application Docs ID
            61809
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          4. Appl No
            202317
            Application Docs Date
            2020-05-04 00:00:00
            Application Docs ID
            62811
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2020-05-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2020-01-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2016-12-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2016-04-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2015-10-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2014-10-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2014-07-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            202317
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2013-08-23 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA202317
          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
          2020-05-01
          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
            202317
            Application Docs Date
            2020-05-04 00:00:00
            Application Docs ID
            62811
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          official application record
          Appl No
          202317
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          HELSINN
          openfda application present
          true
          products
          1. Active Ingredient
            MECHLORETHAMINE HYDROCHLORIDE
            Appl No
            202317
            Drug Name
            VALCHLOR
            Form
            GEL;TOPICAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 0.016% BASE
            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. NDA202317
        brand names
        1. VALCHLOR
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        398
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
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        current approval status
        not_reconciled
        duplicate text group
        dup-5415f327f215718c3506
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. MECHLORETHAMINE HYDROCHLORIDE
        id
        ind-span-302fa6c0d9912c33f9f7
        label id
        942707af-a16c-4a62-b733-103e0fac915e
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is indicated
        label id
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        source text sha256
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        qualifier mentions
        1. context exact
          ycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          197
          end exclusive
          true
          exact text
          who have received prior skin-directed therapy
          label id
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          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
            source span
            end
            198
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
            label id
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            offset unit
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            source text sha256
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            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22942707af-a16c-4a62-b733-103e0fac915e%22
            spl effective date
            2024-11-20
            spl set id
            6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
            spl version
            12
            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
            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA202317
            brand names
            1. VALCHLOR
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            398
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
            label id
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            offset unit
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            source field
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            source text sha256
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            current approval status
            not_reconciled
            duplicate text group
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            extraction review status
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            generic names
            1. MECHLORETHAMINE HYDROCHLORIDE
            id
            ind-span-5946dc2e33a7f7b714fc
            label id
            942707af-a16c-4a62-b733-103e0fac915e
            positive predicate support span
            end
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            end exclusive
            true
            exact text
            is an alkylating drug indicated
            label id
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            unicode_code_points
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            qualifier mentions
            1. context exact
              VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              257
              end exclusive
              true
              exact text
              alkylating drug indicated for the topical t
              label id
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            2. context exact
              ycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              397
              end exclusive
              true
              exact text
              who have received prior skin-directed therapy ( 1 )
              label id
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              offset unit
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              source field
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            regulatory links
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              source defined aliases
                source span
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                end exclusive
                true
                exact text
                VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
                label id
                942707af-a16c-4a62-b733-103e0fac915e
                offset unit
                unicode_code_points
                source array index
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                source field
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                source text sha256
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                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22942707af-a16c-4a62-b733-103e0fac915e%22
                spl effective date
                2024-11-20
                spl set id
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                spl version
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                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
                tumor_directed_candidate

                Preserved source evidence · Not medical advice