Uncomplicated Urinary Tract Infection

• FDA approval · 2024-03-25
  FDA Approved: FOSFOMYCIN TROMETHAMINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's original application for fosfomycin tromethamine (fosfomycin trometamol), a generic antibiotic. It is indicated for tr…

• FDA approval · 2023-12-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…

• FDA approval · 2021-10-21
  FDA Approved: FOSFOMYCIN TROMETHAMINE — Original Application (Kesin Pharma Corporation)

  The FDA approved Kesin Pharma Corporation's original ANDA for fosfomycin tromethamine, authorizing the marketing of a generic antibiotic.

• FDA approval · 2020-04-22
  FDA Approved: LEVOFLOXACIN — Original Application (Gland Pharma Limited)

  FDA approved an original application for levofloxacin from Gland Pharma Limited, authorizing a generic version of the antibiotic.

• FDA approval · 2013-11-22
  FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for cefixime. This action updates the cefixime NDA, potentially expanding i…

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• FDA approval · 2012-11-14
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for nitrofurantoin macrocrystals from Aurobindo Pharma Limited, authorizing a generic version of the…

• FDA approval · 2009-03-05
  FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for nitrofurantoin monohydrate/macrocyrstalline (Alvogen).

• FDA approval · 2007-08-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's amoxicillin/clavulanate potassium as an Original Application (ANDA), granting approval for a generic antibiotic pr…