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LABELS · 4e04737b-8d88-7c75-e063-6394a90a34c0

Tirosint SOL

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
2026-03-27
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including TIROSINT-SOL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ]. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including TIROSINT-SOL, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life threatening manifestations of toxicity ( 6 , 10 ).

Indications and usage: exact source text

  1. 1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use Tirosint-SOL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with TIROSINT-SOL may induce hyperthyroidism [see Warnings and Precautions (5.1) ] . Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
Full extracted label fields
application numbers
  1. NDA206977
boxed warning exact
  1. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including TIROSINT-SOL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ]. WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including TIROSINT-SOL, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life threatening manifestations of toxicity ( 6 , 10 ).
brand names
  1. Tirosint SOL
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d378add-f13d-40f2-99dc-0f2340ab44b7
generic names
  1. LEVOTHYROXINE SODIUM
id
4e04737b-8d88-7c75-e063-6394a90a34c0
indications and usage exact
  1. 1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use Tirosint-SOL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with TIROSINT-SOL may induce hyperthyroidism [see Warnings and Precautions (5.1) ] . Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. IBSA Pharma Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 71858-0105-6
    2. 71858-0105-4
    3. 71858-0105-5
    4. 71858-0105-1
    5. 71858-0105-2
    6. 71858-0110-6
    7. 71858-0110-4
    8. 71858-0110-5
    9. 71858-0110-1
    10. 71858-0110-2
    11. 71858-0112-6
    12. 71858-0112-4
    product ndcs
    1. 71858-0105
    2. 71858-0110
    3. 71858-0112
    4. 71858-0113
    5. 71858-0115
    6. 71858-0117
    7. 71858-0120
    8. 71858-0125
    9. 71858-0130
    10. 71858-0135
    11. 71858-0140
    12. 71858-0145
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. RECENT MAJOR CHANGES Indications and Usage ( 1 ) 11/2023 Dosage and Administration ( 2.1 ) 11/2023 Dosage and Administration ( 2.2 ) 11/2023 Dosage and Administration ( 2.3 ) 11/2023 Warnings and Precautions ( 5.1 ) 11/2023 Warnings and Precautions ( 5.4 ) 11/2023
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    rxcuis
    1. 2056462
    2. 2056466
    3. 2056468
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    5. 2056472
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    source batch
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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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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%224e04737b-8d88-7c75-e063-6394a90a34c0%22
    spl effective date
    2026-03-27
    spl effective time
    20260327
    spl set id
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    spl version
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    substance names
    1. LEVOTHYROXINE SODIUM
    uniis
    1. 9J765S329G
    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
      NDA206977
      payload
      all indexed label documents
      1. Appl No
        206977
        Application Docs Date
        2016-12-21 00:00:00
        Application Docs ID
        46423
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        206977
        Application Docs Date
        2017-02-28 00:00:00
        Application Docs ID
        47368
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        206977
        Application Docs Date
        2022-12-20 00:00:00
        Application Docs ID
        72957
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      4. Appl No
        206977
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76596
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      5. Appl No
        206977
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76597
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        206977
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2023-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        206977
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2023-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        206977
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2021-01-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        206977
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2017-02-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        206977
        Review Priority
        STANDARD
        Submission Class Code ID
        12
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2016-12-15 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      application number
      NDA206977
      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
      2023-11-16
      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
        206977
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76596
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      2. Appl No
        206977
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76597
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      official application record
      Appl No
      206977
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      IBSA
      openfda application present
      true
      products
      1. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        13MCG/ML
        marketing status
        1. Prescription
      2. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        25MCG/ML
        marketing status
        1. Prescription
      3. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        003
        Reference Drug
        1
        Reference Standard
        0
        Strength
        50MCG/ML
        marketing status
        1. Prescription
      4. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        004
        Reference Drug
        1
        Reference Standard
        0
        Strength
        75MCG/ML
        marketing status
        1. Prescription
      5. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        005
        Reference Drug
        1
        Reference Standard
        0
        Strength
        88MCG/ML
        marketing status
        1. Prescription
      6. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        006
        Reference Drug
        1
        Reference Standard
        0
        Strength
        100MCG/ML
        marketing status
        1. Prescription
      7. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        007
        Reference Drug
        1
        Reference Standard
        0
        Strength
        112MCG/ML
        marketing status
        1. Prescription
      8. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        008
        Reference Drug
        1
        Reference Standard
        0
        Strength
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        marketing status
        1. Prescription
      9. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        009
        Reference Drug
        1
        Reference Standard
        0
        Strength
        137MCG/ML
        marketing status
        1. Prescription
      10. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        010
        Reference Drug
        1
        Reference Standard
        0
        Strength
        150MCG/ML
        marketing status
        1. Prescription
      11. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        011
        Reference Drug
        1
        Reference Standard
        0
        Strength
        175MCG/ML
        marketing status
        1. Prescription
      12. Active Ingredient
        LEVOTHYROXINE SODIUM
        Appl No
        206977
        Drug Name
        TIROSINT-SOL
        Form
        SOLUTION;ORAL
        Product No
        012
        Reference Drug
        1
        Reference Standard
        1
        Strength
        200MCG/ML
        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. NDA206977
    brand names
    1. Tirosint SOL
    classification reasons
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    clinical review status
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    content role
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    context span
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    exact text
    1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in
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      ION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroi
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    3. context exact
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    4. context exact
      ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (t
      kind
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      polarity
      not_inferred
      span
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    regulatory links
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        1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
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                        Preserved source evidence · Not medical advice