Heart Failure

• FDA label_change · 2023-06-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA supplemental application for Losartan Potassium by Macleods Pharmaceuticals Limited, likely involving labeling changes for the generic d…

• FDA label_change · 2022-01-12
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) to update the labeling, submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2020-05-19
  FDA Approved: CAPTOPRIL — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for captopril submitted by Solco Healthcare US, LLC, updating the labeling for the generic drug …

• FDA label_change · 2020-04-08
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan from Macleods Pharmaceuticals Limited, indicating changes to the product labeling.

• FDA label_change · 2018-09-20
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc. The action updates the product labeling…

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• FDA label_change · 2018-08-24
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  FDA approves a supplemental application for LANOXIN (digoxin) filed by Covis Pharma US, Inc., resulting in changes to the product labeling.

• FDA label_change · 2018-07-13
  FDA Approved: NIPRIDE RTU — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved a supplemental application for Nipride RTU (sodium nitroprusside) from Exela Pharma Sciences, LLC, updating labeling. Nipride R…

• FDA label_change · 2017-09-14
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, typically involving a label change or n…

• FDA label_change · 2017-09-14
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, detailing changes related to the C…

• FDA label_change · 2017-07-21
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  The FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) by Almatica Pharma Inc., resulting in update…

• FDA label_change · 2016-11-02
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for digoxin from Sandoz Inc, resulting in a label change for the generic heart medication.

• FDA label_change · 2016-02-18
  FDA Approved: LISINOPRIL — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lisinopril submitted by Exelan Pharmaceuticals Inc., typically resulting in labeling updates…

• FDA label_change · 2016-01-06
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Farxiga (dapagliflozin), resulting in changes to the product labeling.

• FDA label_change · 2015-07-28
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Lanoxin (digoxin) submitted by Covis Pharma US, Inc.

• FDA label_change · 2015-07-27
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for DIOVAN (valsartan) submitted by Novartis Pharmaceuticals Corporation, resulting in changes to th…

• FDA label_change · 2015-06-29
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Bisoprolol Fumarate (Natco Pharma USA LLC), resulting in labeling changes for the product.

• FDA label_change · 2015-03-30
  FDA Approved: EDECRIN — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for EDECRIN (ethacrynic acid) submitted by Bausch Health US, LLC, updating the drug's labeling.

• FDA label_change · 2014-09-26
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for carvedilol submitted by Glenmark Pharmaceuticals USA, resulting in changes to the drug’s lab…

• FDA label_change · 2014-05-06
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) filed by Melinta Therapeutics, resulting in labeling changes fo…

• FDA label_change · 2013-11-05
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for ZESTRIL (lisinopril) submitted by Upsher-Smith Laboratories, LLC.

• FDA label_change · 2013-09-27
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA supplemental application for SAMSCA (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc., for a labeling change. The filing indi…

• FDA label_change · 2013-05-21
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental label change for Lanoxin (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA label_change · 2013-05-16
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Eplerenone by Mylan Pharmaceuticals, typically indicating labeling updates.

• FDA label_change · 2013-02-05
  FDA Approved: INDAPAMIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for indapamide from Actavis Pharma, resulting in labeling changes for the product.

• FDA label_change · 2012-10-31
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Zestril (lisinopril) from Upsher-Smith Laboratories, resulting in updated labeling.