Application Nr Approved Date Route Status External Links
NDA021116 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levothyroxine Sodium Tablets Are L-Thyroxine (t4) Indicated 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. - Not Indicated For Treatment Of Hypothyroidism During The Recovery Phase Of Subacute Thyroiditis. Hypothyroidism Levothyroxine Sodium Tablets Are Indicated As A Replacement Therapy In Primary (thyroidal), Secondary (pituitary), And Tertiary (hypothalamic) Congenital Or Acquired Hypothyroidism. Pituitary Thyrotropin (thyroid-Stimulating Hormone, Tsh) Suppression Levothyroxine Sodium Tablets Are Indicated As An Adjunct To Surgery And Radioiodine Therapy In The Management Of Thyrotropin-Dependent Well-Differentiated Thyroid Cancer. Limitations Of Use: Levothyroxine Sodium Tablets Are 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 Levothyroxine Sodium Tablets May Induce Hyperthyroidism [see Warnings And Precautions ( 5.4 )]. Levothyroxine Sodium Tablets Are Not Indicated For Treatment Of Hypothyroidism During The Recovery Phase Of Subacute Thyroiditis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levothyroxine Sodium LEVOTHYROXINE SODIUM ZINC3830993

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