Hepatic Cirrhosis

• FDA approval · 2019-02-26
  FDA Approved: CHLORTHALIDONE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for chlorthalidone, a generic diuretic. This enables marketing of the generic chlo…

• FDA approval · 2018-10-12
  FDA Approved: CHLORTHALIDONE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories Inc.'s original application for chlorthalidone (generic diuretic) under ANDA210742.

• FDA approval · 2018-05-08
  FDA Approved: ETHACRYNIC ACID — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original generic application for Ethacrynic acid from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-01-23
  FDA Approved: BUMETANIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Bumetanide under an Original Application for Upsher-Smith Laboratories, establishing a generic version of the loop diuretic.

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 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…

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

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

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

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

• 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 · 2014-10-20
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for bumetanide from Sandoz Inc.

• 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 · 2012-09-26
  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.

• 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 · 2012-03-27
  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 · 2011-09-22
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA issued a supplemental approval for Torsemide from Rising Pharma Holdings, approving a generic torsemide product.

• 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 · 2011-01-26
  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 · 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 · 2010-03-08
  FDA Approved: BUMETANIDE — Supplemental Application (Sagent Pharmaceuticals)

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

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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