Edema

• FDA approval · 2014-04-23
  FDA Approved: SPIRONOLACTONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original ANDA for spironolactone, authorizing a generic version manufactured by Jubilant Cadista Pharmaceuticals Inc.

• FDA approval · 2014-03-06
  FDA Approved: SPIRONOLACTONE — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's Original Application for spironolactone (generic spironolactone).

• FDA approval · 2014-01-27
  FDA Approved: FUROSEMIDE — Original Application (Civica, Inc.)

  FDA approves Civica, Inc.’s original application for furosemide (generic diuretic).

• FDA approval · 2014-01-22
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Hydrochlorothiazide submitted by Aurobindo Pharma Limited under an Abbreviated New Drug Applicat…

• FDA approval · 2014-01-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the Spironolactone and Hydrochlorothiazide combination product (Prasco Laboratories), indica…

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• FDA approval · 2013-06-12
  FDA Approved: ALDACTONE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Aldactone (spironolactone) from Pfizer. The approval updates the drug’s labeling.

• FDA approval · 2013-02-05
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide from Mylan Pharmaceuticals Inc. (ANDA 086513).

• 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.

• FDA approval · 2012-09-24
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for generic hydrochlorothiazide. The drug is indicated for hypertension and edema.

• FDA approval · 2012-06-11
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories.

• FDA approval · 2012-06-11
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories.

• 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 · 2012-01-19
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories, authorizing changes to the prev…

• FDA approval · 2012-01-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydrochlorothiazide (generic) submitted by Teva Pharmaceuticals USA, Inc., under the ANDA progra…

• 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 · 2011-12-09
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for the generic fixed-dose combination triamterene/hydrochlorothiazide.

• 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 · 2011-11-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2011-10-13
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc., approving a generic hydrochlor…