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 · 2022-08-30
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Synthroid (levothyroxine sodium) submitted by AbbVie, resulting in changes to the product la…

• FDA label_change · 2022-04-14
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  FDA approved a supplemental application for Levothyroxine Sodium submitted by Alvogen, Inc., resulting in updated labeling for the product.

• 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 · 2017-08-31
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  The FDA approved a supplemental application for Levothyroxine Sodium from Alvogen, Inc., resulting in labeling changes for the product.

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• 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 · 2015-11-25
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for SYNTHROID (levothyroxine sodium) submitted by AbbVie, resulting in a label change for the pr…

• FDA label_change · 2013-02-16
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Levothyroxine Sodium (levothyroxine sodium anhydrous) from Fresenius Kabi USA, LLC.

• FDA label_change · 2011-03-21
  FDA Approved: LEVOXYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  This document notes an FDA supplemental application for LEVOXYL (levothyroxine sodium) submitted by Pfizer Laboratories Div Pfizer Inc, gene…

• 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…

• FDA label_change · 2009-03-26
  FDA Approved: EUTHYROX — Supplemental Application (Provell Pharmaceuticals, LLC)

  FDA approved a supplemental application for EUTHYROX (levothyroxine sodium) from Provell Pharmaceuticals, LLC, indicating a modification to …