Hypothyroidism

• FDA approval · 2020-11-30
  FDA Approved: THYQUIDITY — Original Application (Oliva Therapeutics, LLC)

  FDA approved THYQUIDITY (levothyroxine sodium) from Oliva Therapeutics, LLC via an Original New Drug Application.

• 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 · 2020-01-21
  FDA Approved: CYTOMEL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cytomel (liothyronine sodium) from Pfizer, leading to changes to the product labeling.

• FDA approval · 2019-12-23
  FDA Approved: LIOTHYRONINE SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Liothyronine Sodium by Teva Pharmaceuticals USA, Inc.

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• FDA approval · 2019-12-23
  FDA Approved: LIOMNY — Supplemental Application (SIGMAPHARM LABORATORIES, LLC)

  The FDA approved a supplemental application for LIOMNY (liothyronine sodium) submitted by SigmaPharm Laboratories, LLC.

• FDA approval · 2019-12-17
  FDA Approved: LIOTHYRONINE SODIUM — Supplemental Application (Dr. Reddy's Labratories Inc.)

  The FDA approved a supplemental application for Liothyronine Sodium from Dr. Reddy's Laboratories Inc., under ANDA090097, authorizing a chan…

• 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 · 2018-12-21
  FDA Approved: CYTOMEL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Cytomel (liothyronine sodium) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2018-12-21
  FDA Approved: LEVOTHYROXINE SODIUM — Original Application (Sagent Pharmaceuticals)

  FDA approved the original application for Levothyroxine Sodium (levothyroxine sodium anhydrous) from Sagent Pharmaceuticals.

• 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 · 2018-10-26
  FDA Approved: LIOTHYRONINE SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s liothyronine sodium as a generic product (ANDA 211510).

• FDA approval · 2018-09-14
  FDA Approved: EUTHYROX — Supplemental Application (Provell Pharmaceuticals, LLC)

  FDA approved a supplemental application for EUTHYROX (levothyroxine sodium) from Provell Pharmaceuticals, LLC, updating the product labeling…

• 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 · 2017-12-05
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Lannett Company, Inc)

  FDA approved a supplemental application for levothyroxine sodium submitted by Lannett Company, Inc.

• FDA approval · 2017-04-25
  FDA Approved: TIROSINT — Supplemental Application (IBSA Pharma Inc.)

  The FDA approved a supplemental application for TIROSINT (levothyroxine sodium) submitted by IBSA Pharma Inc.

• 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 · 2016-12-15
  FDA Approved: TIROSINT SOL — Original Application (IBSA Pharma Inc.)

  FDA approved TIROSINT SOL (levothyroxine sodium) from IBSA Pharma Inc. in an original NDA, introducing a new brand/formulation of thyroid ho…

• 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 · 2016-05-19
  FDA Approved: LEVOTHYROXINE SODIUM — Supplemental Application (Alvogen, Inc.)

  The FDA approved a supplemental application for levothyroxine sodium submitted by Alvogen, Inc., indicating an approved change to an existin…

• FDA approval · 2016-04-20
  FDA Approved: LIOTHYRONINE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved the original ANDA for Liothyronine Sodium, a generic thyroid hormone replacement. The product is manufactured by Sun Pharmaceut…