Cirrhosis with Ascites

• CLINICAL_TRIALS trial_result · 2026-03-10
  Clinical Trial Update: Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites [Phase 2, Phase 3]

  This document provides an update on a Phase II/III trial evaluating recombinant human serum albumin in patients with cirrhosis and ascites, …

• FDA approval · 2025-01-23
  FDA Approved: SPIRONOLACTONE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original application for spironolactone (generic) from Rising Pharma Holdings, Inc., authorizing the marketing of a gen…

• FDA approval · 2023-09-05
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic spironolactone. This action confirms approval of modifications under…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for spironolactone from Oxford Pharmaceuticals, LLC, under the existing ANDA.

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• FDA approval · 2020-05-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved Ipca Laboratories Limited's supplemental application for furosemide under an ANDA, updating the approved product.

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA has approved a supplemental application for spironolactone from Jubilant Cadista Pharmaceuticals Inc. under the ANDA framework.

• 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 · 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 · 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…

• CLINICAL_TRIALS trial_result · 2009-07-28
  Clinical Trial Update: Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics [Phase 3]

  A Phase 3 trial evaluating the safety and efficacy of a synbiotic for the incidence and recurrence of spontaneous bacterial peritonitis in p…

• 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 …

• CLINICAL_TRIALS trial_result · 2008-04-14
  Clinical Trial Update: Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function [Phase 2]

  This Phase 2 clinical trial from the University of Turin investigates whether hydrocortisone improves renal and haemodynamic function in pat…