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LABELS · 9f2892be-8330-4fd1-930e-b4d204df4e03

Condylox

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
2024-01-29
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
Full extracted label fields
application numbers
  1. NDA020529
boxed warning exact
    brand names
    1. Condylox
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=032e4bcb-b1ed-4029-b2a6-e92f3bf5cc37
    generic names
    1. PODOFILOX
    id
    9f2892be-8330-4fd1-930e-b4d204df4e03
    indications and usage exact
    1. INDICATIONS AND USAGE Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Allergan, Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 0023-6118-03
      product ndcs
      1. 0023-6118
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. TOPICAL
        rxcuis
        1. 312466
        2. 351750
        source batch
        file
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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
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        total
        830
        sha256
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        url
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        source url
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        spl effective date
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        spl effective time
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        spl version
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        substance names
        1. PODOFILOX
        uniis
        1. L36H50F353
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA020529
          payload
          all indexed label documents
          1. Appl No
            020529
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56705
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            020529
            Review Priority
            STANDARD
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1997-03-13 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            020529
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1997-03-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020529
          approval interpretation
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          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
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          latest label selection rule
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          latest posted label documents
          1. Appl No
            020529
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56705
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
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          official application record
          Appl No
          020529
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ALLERGAN
          openfda application present
          true
          products
          1. Active Ingredient
            PODOFILOX
            Appl No
            020529
            Drug Name
            CONDYLOX
            Form
            GEL;TOPICAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.5%
            marketing status
            1. 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
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        brand names
        1. Condylox
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        clinical review status
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        343
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        true
        exact text
        INDICATIONS AND USAGE Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should b
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              INDICATIONS AND USAGE Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts).
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              structured indication
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              biomarker and test
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              line
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              use intent
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              Passage 2 · limitation of use
              application numbers
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              exact text
              INDICATIONS AND USAGE Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell
              label id
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                    This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ).
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                    source url
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                    spl effective date
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                    spl set id
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                    structured fields status
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                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
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                    tumor histology
                    Source null
                    use intent
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                    Passage 3 · unclassified context
                    application numbers
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                    exact text
                    .5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be trea
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                    label id
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                    positive predicate support span
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                          exact text
                          Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis.
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                          source url
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                          spl effective date
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                          structured indication
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                          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
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                          tumor histology
                          Source null
                          use intent
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                          Passage 4 · unclassified context
                          application numbers
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                          brand names
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                          clinical review status
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                          mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
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                                Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern.
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                                Passage 5 · risk or warning
                                application numbers
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                                pearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
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                                      Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel 0.5%.
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                                      Source null
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                                      Source null
                                      limitations
                                      Source null
                                      line
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                                      Source null
                                      regimen
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                                      tumor histology
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                                      use intent
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                                      Preserved source evidence · Not medical advice