Congenital Hypothyroidism

• FDA label_change · 2023-07-20
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA supplemental application filed for Levothyroxine Sodium by Mylan Pharmaceuticals Inc., an approved generic, likely to address labeling c…

• FDA label_change · 2020-07-15
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Synthroid (levothyroxine sodium) by AbbVie, resulting in a labeling change. The action updates t…

• FDA label_change · 2017-02-23
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  FDA approved a labeling supplement for Synthroid (levothyroxine sodium) submitted by AbbVie, updating the drug’s labeling.

• FDA label_change · 2009-09-01
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA has approved a supplemental application for levothyroxine sodium from Amneal Pharmaceuticals NY LLC, updating labeling and related regul…