Heart Failure

• FDA approval · 2020-05-04
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc., under the Torsemide product line.

• FDA approval · 2020-04-29
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals, advancing an update to an e…

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, approving a generic lisinopril product.

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for lisinopril submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for Enalapril Maleate and Hydrochlorothiazide from Taro Pharmaceuticals U.S.A., Inc., enabling a…

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• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate (generic enalapril) submitted by Northstar RxLLC, effectively granting a suppl…

• FDA approval · 2020-04-06
  FDA Approved: BUMETANIDE — Supplemental Application (NorthStar Rx, LLC)

  The FDA approved a supplemental application for bumetanide submitted by NorthStar Rx, LLC.

• FDA approval · 2020-04-06
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for bumetanide (generic) under an ANDA.

• FDA approval · 2020-03-31
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved an original ANDA for metoprolol succinate, a generic product manufactured by Nivagen Pharmaceuticals, Inc.

• FDA approval · 2020-03-24
  FDA Approved: MILRINONE LACTATE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved milrinone lactate from Meitheal Pharmaceuticals as an original application (ANDA) approval for a generic milrinone lactate prod…

• FDA approval · 2020-03-11
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol (Advagen Pharma Ltd) under an ANDA, authorizing a supplemental approval for this gene…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CAPTOPRIL by Camber Pharmaceuticals, granting approval of an additional generic captopril produc…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL (captopril) from Hikma Pharmaceuticals USA Inc. under an ANDA. The action concerns…

• FDA approval · 2020-03-03
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC, approving an updated generic product.

• FDA approval · 2020-03-02
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, resulting in updated labeling. The approval confirms c…

• FDA approval · 2020-02-19
  FDA Approved: ETHACRYNIC ACID — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's original generic application for Ethacrynic acid, a loop diuretic.

• FDA approval · 2019-12-13
  FDA Approved: CAPTOPRIL — Original Application (Ajanta Pharma USA Inc.)

  This document reports the FDA approval of CAPTOPRIL as a generic product (Original Application) by Ajanta Pharma USA Inc.

• FDA approval · 2019-12-12
  FDA Approved: BUMETANIDE — Original Application (Rising Pharma Holdings, Inc)

  FDA approved an original ANDA for bumetanide from Rising Pharma Holdings, Inc, making the generic diuretic available.

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals Inc., enabling continued marketing of the product and …

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA has approved a supplemental application for spironolactone from Jubilant Cadista Pharmaceuticals Inc. under the ANDA framework.

• FDA approval · 2019-11-06
  FDA Approved: VALSARTAN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for valsartan from Ascend Laboratories, updating the regulatory status of this generic antihypertens…

• FDA approval · 2019-11-01
  FDA Approved: QUINAPRIL — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for quinapril filed by Solco Healthcare US, LLC under ANDA205823.

• FDA approval · 2019-11-01
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a generic fixed-dose combination of spironolactone and hydrochlorothiazide from Sun Pharmace…

• FDA approval · 2019-10-04
  FDA Approved: DIGOXIN — Original Application (VistaPharm, LLC)

  The FDA approved VistaPharm’s original (ANDA) application for digoxin, granting marketing approval for a generic digoxin product.