Uncomplicated Cystitis

• FDA approval · 2023-12-11
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for nitrofurantoin (Macrocrystals) from Aurobindo Pharma Limited.

• FDA approval · 2019-06-11
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Nitrofurantoin filed by Rising Pharma Holdings, Inc.

• FDA approval · 2018-07-09
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals’ nitrofurantoin macrocrystals as an original ANDA generic product for the treatment of urinary tract infe…

• CLINICAL_TRIALS research · 2015-10-22
  Clinical Trial Update: Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice

  Completed clinical trial investigating the epidemiology of acute uncomplicated bacterial cystitis in general practice.

• FDA approval · 2015-10-02
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Alvogen Inc.)

  The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Alvogen, expanding the approved formulation.

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• FDA approval · 2015-01-15
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Nitrofurantoin (Macrocrystals) from Aurobindo Pharma Limited.

• FDA label_change · 2014-06-25
  FDA Approved: NITROFURANTOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for nitrofurantoin from Amneal Pharmaceuticals NY LLC (generic nitrofurantoin), likely involving…

• CLINICAL_TRIALS trial_result · 2010-06-29
  Clinical Trial Update: Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis [Phase 3]

  A Phase 3 trial comparing cefditoren pivoxil to ciprofloxacin in acute uncomplicated cystitis reports efficacy and safety data.