Goiter

• FDA approval · 2025-03-05
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Fosun Pharma USA Inc.)

  FDA approves Fosun Pharma USA Inc.'s Levothyroxine Sodium anhydrous as a generic product under Original ANDA for thyroid hormone replacement…

• FDA approval · 2024-09-16
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's levothyroxine sodium, resulting in a generic product approval for thyroid ho…

• FDA approval · 2024-02-20
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Synthroid (levothyroxine sodium) from AbbVie, resulting in changes to the product's labeling.

• FDA approval · 2023-11-16
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  The FDA approved a supplemental application for Levothyroxine Sodium by Alvogen, Inc., updating the regulatory status for this product under…

• FDA approval · 2022-12-21
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (NorthStar RxLLC)

  FDA approved the original application for levothyroxine sodium as a generic thyroid hormone replacement product from NorthStar RxLLC.

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• FDA approval · 2022-05-10
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva’s generic levothyroxine sodium product under an Original Application (ANDA 207588).

• FDA approval · 2021-05-17
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a Levothyroxine Sodium original application product from Hikma Pharmaceuticals USA Inc. as a thyroid hormone replacement therap…

• FDA approval · 2020-11-05
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Levothyroxine Sodium from Mylan Pharmaceuticals under an ANDA, authorizing the change descri…

• FDA approval · 2020-10-19
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Accord Healthcare Inc.)

  FDA approved an original application for Levothyroxine Sodium from Accord Healthcare Inc. as a generic thyroid hormone replacement product.

• FDA approval · 2019-06-03
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Levothyroxine Sodium from Lupin Pharmaceuticals, Inc. This action updates the product's labeling…

• FDA approval · 2019-04-23
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  FDA approved a supplemental application for Levothyroxine Sodium (Alvogen, Inc.), authorizing changes to the product labeling.

• FDA approval · 2019-04-11
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved a new Levothyroxine sodium product from Fresenius Kabi USA, LLC under its Original Application. Levothyroxine is a thyroid …

• FDA approval · 2019-01-18
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic levothyroxine sodium as an original application, authorizing its use as a thyroid hormone replac…

• FDA approval · 2018-12-10
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for levothyroxine sodium from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2017-12-08
  FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)

  The FDA approved a supplemental application for TIROSINT (levothyroxine sodium) by IBSA Pharma Inc., updating the product labeling as part o…

• FDA approval · 2017-02-24
  FDA Approved: TIROSINT SOL — Supplemental Application (IBSA Pharma Inc.)

  The FDA approved a supplemental application for TIROSINT SOL (levothyroxine sodium) from IBSA Pharma Inc., a thyroid hormone replacement the…

• FDA approval · 2017-01-12
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  The FDA approved a supplemental application for Levothyroxine Sodium from Lannett Company, Inc, enabling the marketed generic product.

• FDA approval · 2016-03-24
  FDA Approved: POTASSIUM IODIDE — Original Application (Mission Pharmacal Company)

  FDA approved an original-application generic potassium iodide product from Mission Pharmacal Company.

• FDA approval · 2015-04-15
  FDA Approved: SYNTHROID — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Synthroid (levothyroxine sodium) filed by AbbVie, indicating an approved change to the product's…

• FDA approval · 2014-05-06
  FDA Approved: LEVOXYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for LEVOXYL (levothyroxine sodium) submitted by Pfizer Laboratories Div Pfizer Inc. The action repre…

• FDA approval · 2012-12-20
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Levothyroxine Sodium (Levothyroxine Sodium Anhydrous) by Fresenius Kabi USA, LLC.

• FDA approval · 2012-12-14
  FDA Approved: LEVOXYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Pfizer's supplemental application for LEVOXYL (levothyroxine sodium), resulting in labeling updates for its use in hypothyroidi…

• FDA approval · 2012-11-20
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  FDA approved a supplemental application for levothyroxine sodium from Lannett Company, Inc., supporting the generic product's continued mark…

• FDA approval · 2012-03-04
  FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)

  The FDA approved a supplemental application for TIROSINT (levothyroxine sodium) submitted by IBSA Pharma Inc., updating the product labeling…

• FDA approval · 2011-03-09
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  FDA approved the supplemental application for Levothyroxine Sodium from Lannett Company, Inc, authorizing the marketing of this generic prod…