Hyperthyroidism

• FDA approval · 2015-02-10
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Propylthiouracil submitted by Endo USA, Inc., resulting in updated labeling for the product. Thi…

• FDA approval · 2015-02-03
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for HICON (Sodium iodide I-131) from Jubilant DraxImage Inc., dba Jubilant Radiopharma.

• FDA approval · 2013-12-19
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental NDA for Propylthiouracil submitted by Endo USA, Inc., updating the labeling to reflect the approved changes.…

• FDA approval · 2012-07-11
  FDA Approved: METHIMAZOLE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for methimazole filed by Strides Pharma Science Limited.

• FDA approval · 2012-07-11
  FDA Approved: METHIMAZOLE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for methimazole submitted by Chartwell RX, LLC under ANDA 040411. This action implements modific…

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• FDA approval · 2012-03-07
  FDA Approved: METHIMAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original application for methimazole, a generic antithyroid medication used to treat hyperthyroi…

• FDA approval · 2011-10-13
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Propylthiouracil from Actavis Pharma, Inc., under the ANDA pathway.

• FDA approval · 2011-10-03
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for HICON (Sodium Iodide I-131) from Jubilant Radiopharma, updating the product labeling to reflect …

• FDA approval · 2011-09-23
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  The FDA approved a supplemental application for HICON (Sodium Iodide I-131) from Jubilant DraxImage Inc., dba Jubilant Radiopharma. The appr…

• FDA approval · 2011-08-22
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  The FDA approved a supplemental ANDA for propylthiouracil from Quagen Pharmaceuticals LLC, authorizing the marketing of an additional generi…

• FDA approval · 2011-08-22
  FDA Approved: METHIMAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for methimazole submitted by Chartwell RX, LLC. This action updates the product's labeling/manufactu…

• FDA approval · 2011-07-27
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Propylthiouracil from Endo USA, Inc., approving changes to the product labeling.

• FDA approval · 2011-03-28
  FDA Approved: METHIMAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for methimazole submitted by Chartwell RX, LLC.

• FDA approval · 2011-01-21
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Propylthiouracil by Actavis Pharma, Inc., indicating a labeling update under the already app…

• FDA approval · 2010-12-29
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved a supplemental application for Propylthiouracil from Quagen Pharmaceuticals LLC (ANDA).

• FDA approval · 2010-12-15
  FDA Approved: PROPYLTHIOURACIL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Propylthiouracil from Actavis Pharma, Inc., for the generic drug Propylthiouracil.

• FDA approval · 2007-12-14
  FDA Approved: METHIMAZOLE — Original Application (NORTHSTAR RX LLC)

  FDA approved NorthStar RX LLC's original ANDA for methimazole, a generic antithyroid medication used to treat hyperthyroidism.

• FDA approval · 2007-04-18
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  The FDA approved a supplemental application for HICON (sodium iodide I-131) submitted by Jubilant DraxImage Inc., dba Jubilant Radiopharma.