Edema

• FDA approval · 2011-09-22
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for the spironolactone and hydrochlorothiazide combination from Prasco Laboratories. This action upd…

• FDA approval · 2011-08-17
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Hydrochlorothiazide from Alembic Pharmaceuticals Limited, adding a generic version of the diuret…

• 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 · 2011-07-14
  FDA Approved: ACETAZOLAMIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved the original ANDA for Acetazolamide from Westminster Pharmaceuticals, making a generic version of the carbonic anhydrase inhibi…

• FDA approval · 2011-05-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the Spironolactone and Hydrochlorothiazide combination submitted by Prasco Laboratories.

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• FDA approval · 2011-03-10
  FDA Approved: METOLAZONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for metolazone by Sandoz Inc. It is a diuretic used to treat edema and hypertension.

• 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 · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for furosemide from Ipca Laboratories Limited under an ANDA, signaling approval of changes to the ge…

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

  FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., updating or adding to the product's labeling and…

• 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 · 2010-09-28
  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 · 2010-01-25
  FDA Approved: INDAPAMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for indapamide from Rising Pharma Holdings, Inc., enabling updated labeling for the generic diur…

• 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 · 2010-01-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved an original application for a generic hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc. under an ANDA; the produ…

• 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…

• FDA approval · 2009-06-10
  FDA Approved: DIURIL — Supplemental Application (Salix Pharmaceuticals, Inc)

  The FDA approved a supplemental application for DIURIL (chlorothiazide) submitted by Salix Pharmaceuticals.

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

  FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., updating the labeling on an existing product.

• 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.

• 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.

• FDA approval · 2009-04-30
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental ANDA for spironolactone, granting approval of their generic product for the …

• FDA approval · 2009-04-29
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide submitted by BluePoint Laboratories. The product is a generi…