Nephrotic Syndrome

• FDA approval · 2009-09-24
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation, authorizing changes to the …

• 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 · 2009-04-30
  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 · 2009-03-12
  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.

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• 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.

• FDA approval · 2009-01-27
  FDA Approved: TORSEMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic torsemide (Original Application), authorizing the generic torsemide tablet for edema associated…

• 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 · 2008-04-10
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's supplemental application for Torsemide, enabling the requested changes to the product's approval.

• FDA approval · 2007-11-07
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide from Chartwell RX, LLC, updating the label for this generic diuretic.

• 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 · 2007-10-03
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Torsemide from Chartwell RX, LLC.

• 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.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., approving regulatory action on an existing generic…

• 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 · 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…