Congenital Hypothyroidism

• 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 · 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 · 2023-07-21
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Levothyroxine Sodium, a generic product used to treat hypothyroidism and re…

• 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.

• FDA approval · 2022-10-31
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for levothyroxine sodium from Accord Healthcare Inc. under an ANDA.

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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 · 2020-10-19
  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 · 2019-04-23
  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 · 2016-06-29
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Piramal Critical Care, Inc.)

  FDA approved Piramal Critical Care's levothyroxine sodium as an original application (ANDA206163), providing a generic option for thyroid ho…

• FDA approval · 2015-11-09
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  FDA approved a Supplemental Application for Levothyroxine Sodium from Alvogen, Inc. to continue regulatory recognition of the drug under its…

• FDA approval · 2015-02-09
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  The FDA approved a supplemental application for LEVOTHYROXINE SODIUM from Lannett Company, Inc., updating or expanding the labeling for the …

• 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 · 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…

• FDA approval · 2008-10-30
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for levothyroxine sodium from Mylan Pharmaceuticals Inc., granting regulatory approval for this gene…

• FDA approval · 2008-06-10
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  The FDA approved a supplemental application for levothyroxine sodium submitted by Lannett Company, Inc., authorizing continued marketing of …

• FDA approval · 2007-12-17
  FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)

  FDA approved a supplemental application for TIROSINT (levothyroxine sodium) submitted by IBSA Pharma Inc., expanding the regulatory approval…

• FDA approval · 2006-12-13
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Levothyroxine Sodium from Mylan Pharmaceuticals Inc. (ANDA 076187).

• FDA approval · 2006-10-13
  FDA Approved: TIROSINT — Original Application (IBSA Pharma Inc.)

  FDA approved TIROSINT (levothyroxine sodium) from IBSA Pharma Inc. as an Original Application (NDA021924) for replacement therapy in thyroid…