Edema

• FDA approval · 2009-03-12
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC, resulting in updated labeling for the product.

• FDA approval · 2009-02-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Spironolactone submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2009-02-20
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  The FDA approved a supplemental application for furosemide from Solco Healthcare LLC, adding a new manufacturing source for the product.

• FDA approval · 2009-02-06
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2009-01-30
  FDA Approved: AMILORIDE HYDROCHLORIDE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approves Sigmapharm Laboratories, LLC's amiloride hydrochloride as an original generic application (ANDA) product space.

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• FDA approval · 2008-12-10
  FDA Approved: ACETAZOLAMIDE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approves a generic acetazolamide product (Diamox) from XGen Pharmaceuticals DJB, Inc. under an Original Application.

• FDA approval · 2008-10-22
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2008-08-15
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Exelan Pharmaceuticals Inc.)

  The FDA approved Exelan Pharmaceuticals Inc.'s original application for hydrochlorothiazide, a generic diuretic indicated for hypertension a…

• FDA approval · 2008-05-09
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide by Chartwell RX, LLC, updating an approved generic product (ANDA).

• FDA approval · 2008-05-01
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by Leading Pharma, LLC. This action updates the drug's labelin…

• FDA approval · 2007-11-01
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from Sandoz Inc. This action approves a supplement to the or…

• FDA approval · 2007-10-17
  FDA Approved: TORSEMIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original Abbreviated New Drug Application for torsemide from Rising Pharma Holdings, granting regulatory clearance for a ge…

• FDA approval · 2007-09-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved hydrochlorothiazide from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2007-08-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide submitted by Solco Healthcare LLC.

• FDA approval · 2007-08-06
  FDA Approved: DIURIL — Supplemental Application (Salix Pharmaceuticals, Inc)

  The FDA approved a supplemental application for Salix's Diuril (chlorothiazide), approving changes to its labeling as part of the supplement…

• FDA approval · 2007-07-20
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for HYDROCHLOROTHIAZIDE from Aurobindo Pharma Limited, approving a generic hydrochlorothiazide product…

• FDA approval · 2007-06-29
  FDA Approved: FUROSEMIDE — Supplemental Application (Leading Pharma, LLC)

  FDA approves a supplemental application for furosemide submitted by Leading Pharma, LLC.

• FDA approval · 2007-03-28
  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 ANDA.

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., resulting in changes to the product labeling…

• FDA approval · 2007-03-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Leading Pharma, LLC)

  FDA approved hydrochlorothiazide under Leading Pharma, LLC's original application (ANDA) for use as a diuretic to treat hypertension and ede…

• FDA approval · 2007-02-27
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic hydrochlorothiazide under an original ANDA from Actavis Pharma, Inc.

• FDA approval · 2006-09-18
  FDA Approved: FUROSEMIDE — Original Application (Ipca Laboratories Limited)

  FDA approved the Original Application for furosemide from Ipca Laboratories Limited, enabling a generic version of the diuretic to be market…