Edema

• FDA approval · 2017-07-14
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc. The notice confirms regulatory approval o…

• FDA approval · 2017-03-30
  FDA Approved: CHLORTHALIDONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for chlorthalidone from Rising Pharma Holdings, Inc., a generic diuretic indicated for hypertension and…

• FDA approval · 2017-01-26
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Actavis Pharma, Inc. to update the product labeling.

• FDA approval · 2016-10-27
  FDA Approved: ACETAZOLAMIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for acetazolamide from Chartwell RX, LLC.

• FDA approval · 2016-09-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for furosemide, initiating a supplemental approval for the drug. The action updates th…

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• FDA approval · 2016-09-19
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-09-19
  FDA Approved: SPIRONOLACTONE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for spironolactone (generic), authorizing its use as a potassium-sparing diureti…

• FDA approval · 2016-07-20
  FDA Approved: FUROSEMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2016-06-30
  FDA Approved: ETHACRYNIC ACID — Original Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved Edenbridge Pharmaceuticals' original application for Ethacrynic acid, a loop diuretic used to treat edema associated with h…

• FDA approval · 2016-06-14
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2016-03-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-03-07
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Exelan Pharmaceuticals Inc. (ANDA).

• FDA approval · 2016-03-04
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2016-01-05
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for a generic fixed-dose combination of spironolactone and hydrochlorothiazide produced by Mylan Pha…

• FDA approval · 2015-11-18
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (GSMS, Incorporated)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide combination from GSMS, Incorporated.

• FDA approval · 2015-09-28
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2015-09-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for HYDROCHLOROTHIAZIDE from Actavis Pharma, Inc., indicating an approved change to the product labe…

• FDA approval · 2015-08-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2015-06-05
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide from Marlex Pharmaceuticals, Inc., updating the product label.

• FDA approval · 2015-04-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…

• FDA approval · 2014-12-19
  FDA Approved: ACETAZOLAMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original application for acetazolamide from Heritage Pharmaceuticals (Avet) as a generic drug product.

• FDA approval · 2014-10-22
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Prasco Laboratories.

• FDA approval · 2014-09-24
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Sun Pharmaceutical Ind…

• FDA approval · 2014-08-26
  FDA Approved: FUROSEMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' generic furosemide (ANDA 203428) for edema-related indications and hypertension, enabling a generic v…

• FDA approval · 2014-07-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application for Hydrochlorothiazide (ScieGen Pharmaceuticals, Inc.), a generic diuretic. It is indicated for hyper…