Urinary Tract Infection

• FDA approval · 2019-08-01
  FDA Approved: METHENAMINE HIPPURATE — Original Application (Micro Labs Limited)

  FDA approved the original application for methenamine hippurate (Methenamine Hippurate) manufactured by Micro Labs 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 · 2019-04-19
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Amoxicillin and clavulanate potassium from Aurobindo Pharma Limited, a generic antibiotic product.

• 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…

• FDA approval · 2018-05-24
  FDA Approved: NITROFURANTOIN — Original Application (Trigen Laboratories, LLC)

  FDA approved an original application for nitrofurantoin from Trigen Laboratories, enabling the marketing of a generic antibiotic for urinary…

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• FDA approval · 2017-12-12
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the Original Application for NITROFURANTOIN MACROCRYSTALS from Zydus Pharmaceuticals (USA) Inc., a generic nitrofurantoin produ…

• FDA approval · 2017-12-01
  FDA Approved: METHENAMINE HIPPURATE — Supplemental Application (Esjay Pharma LLC)

  FDA approved a supplemental application for methenamine hippurate submitted by Esjay Pharma LLC.

• FDA approval · 2017-01-13
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Provepharm Inc.)

  FDA approved a generic combination product of piperacillin and tazobactam (piperacillin sodium and tazobactam sodium) from Provepharm Inc. u…

• FDA approval · 2016-10-26
  FDA Approved: ZERBAXA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for ZERBAXA (ceftolozane/tazobactam) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2016-07-11
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for nitrofurantoin from Rising Pharma Holdings, Inc.

• FDA approval · 2016-07-05
  FDA Approved: METHENAMINE HIPPURATE — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's original application for methenamine hippurate, a generic drug used to prevent urinary tract infections.

• FDA approval · 2016-06-24
  FDA Approved: NITROFURANTOIN — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for nitrofurantoin (generic).

• FDA approval · 2016-04-12
  FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…

• FDA approval · 2016-02-16
  FDA Approved: NITROFURANTION — Original Application (BluePoint Labortories)

  The FDA approved the Original Application (ANDA201722) for NITROFURANTION by BluePoint Labortories, authorizing its marketing as a generic d…

• FDA approval · 2015-10-15
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for nitrofurantoin macrocrystals from Alvogen Inc.

• 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.

• FDA approval · 2015-04-17
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for nitrofurantoin macrocrystals filed by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2015-04-17
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Amneal Pharmaceuticals of New York LLC, updating the existing …

• FDA approval · 2015-03-30
  FDA Approved: METHENAMINE HIPPURATE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for methenamine hippurate submitted by Alvogen Inc. This action updates the product's regulatory app…

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

  FDA approved a supplemental application for Nitrofurantoin (Macrocrystals) from Aurobindo Pharma Limited, indicating regulatory approval of …

• 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 approval · 2014-12-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…

• FDA approval · 2014-11-08
  FDA Approved: LEVOFLOXACIN — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for Levofloxacin submitted by Sagent Pharmaceuticals, approving changes to the generic labeling …

• FDA approval · 2014-11-03
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for nitrofurantoin submitted by Rising Pharma Holdings, Inc. to modify the labeling and/or indic…

• FDA approval · 2014-09-08
  FDA Approved: NITROFURANTOIN — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' nitrofurantoin as an Original Application generic product.