Nephrotic Syndrome

• FDA approval · 2013-01-07
  FDA Approved: TORSEMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' torsemide supplemental application (ANDA 079234), resulting in an approved updated torsemide product un…

• FDA approval · 2012-12-12
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc., updating or expanding the product's labeling.

• FDA approval · 2012-11-30
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for furosemide from Ipca Laboratories Limited, indicating approval of their generic furosemide p…

• FDA approval · 2012-09-26
  FDA Approved: TORSEMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals, Inc.'s supplemental application for torsemide, authorizing a modification to the torsemide product unde…

• FDA approval · 2012-09-26
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for torsemide from Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2012-09-18
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for torsemide from Rising Pharma Holdings, Inc., indicating regulatory approval of changes to the to…

• FDA approval · 2012-05-11
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., authorizing a generic version of the diuretic. Thi…

• FDA approval · 2012-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-05-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC, authorizing continued production and marketing of the gene…

• FDA approval · 2012-03-27
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2011-12-31
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approves Solco Healthcare U.S., LLC's supplemental application for hydrochlorothiazide, enabling continued supply of the generic diureti…

• FDA approval · 2011-12-14
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2011-11-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for spironolactone filed by Amneal Pharmaceuticals LLC, a generic product. The approval confirms cha…

• FDA approval · 2011-09-21
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc. This approval pertains to a supplemental submissio…

• FDA approval · 2011-07-26
  FDA Approved: CHLOROTHIAZIDE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original application for CHLOROTHIAZIDE SODIUM, a thiazide diuretic, for the treatment of hypert…

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC under an ANDA, authorizing a manufacturing or labeling chan…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for furosemide, a generic diuretic, under the existing ANDA.

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., authorizing a change to the NDA (such as lab…

• FDA approval · 2010-12-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide filed by Chartwell RX, LLC, authorizing changes under the supplemental NDA. The appro…

• FDA approval · 2010-10-18
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for LASIX (furosemide) from Validus Pharmaceuticals LLC.

• FDA approval · 2010-09-28
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for torsemide submitted by Chartwell RX, LLC under ANDA 076894. The action approves changes to t…

• FDA approval · 2010-07-02
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for generic spironolactone, establishing a bioequivalent product to the refer…

• FDA approval · 2010-03-08
  FDA Approved: BUMETANIDE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for Bumetanide submitted by Sagent Pharmaceuticals.

• FDA approval · 2010-01-21
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2009-10-16
  FDA Approved: CHLOROTHIAZIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original abbreviated new drug application for chlorothiazide sodium, a thiazide diuretic. The product…