Cystitis

• FDA approval · 2025-07-02
  FDA Approved: NITROFURANTOIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for nitrofurantoin, a generic antibiotic. The approval covers its use for urinary tract i…

• FDA approval · 2025-03-21
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for nitrofurantoin macrocrystals from Lifestar Pharma LLC, indicating an approved change to this pro…

• FDA approval · 2024-10-02
  FDA Approved: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for nitrofurantoin macrocrystals (nitrofurantoin) from Aurobindo Pharma Limited, representing a supp…

• 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: NITROFURANTOIN (MACROCRYSTALS) — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for nitrofurantoin macrocrystals from Aurobindo Pharma Limited.

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• FDA approval · 2023-11-03
  FDA Approved: NITROFURANTOIN — Original Application (Micro Labs Limited)

  FDA approves the original application for Nitrofurantoin from Micro Labs Limited as a generic drug.

• FDA approval · 2023-08-08
  FDA Approved: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for nitrofurantoin monohydrate/macrocrystals filed by Sandoz Inc.

• FDA approval · 2023-04-28
  FDA Approved: NITROFURANTOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA granted supplemental approval for nitrofurantoin filed by Amneal Pharmaceuticals NY LLC (ANDA201679), authorizing its marketing as a gen…

• FDA approval · 2023-03-30
  FDA Approved: NITROFURANTOIN — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic nitrofurantoin product (nitrofurantoin monohydrate/macrocrystals) under an Original Application (ANDA209225) from Aur…

• FDA approval · 2022-02-08
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Zydus Pharmaceuticals (USA) Inc., updating an aspect of th…

• FDA approval · 2022-01-26
  FDA Approved: FOSFOMYCIN TROMETHAMINE — Original Application (Cipla USA Inc.)

  FDA approved the original application for fosfomycin tromethamine, a generic antibiotic, manufactured by Cipla USA Inc.

• 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 · 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…

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

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

• 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 · 2013-11-04
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

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

• FDA approval · 2013-09-06
  FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)

  FDA approves a supplemental application for nitrofurantoin monohydrate/macrocrystalline submitted by Alvogen Inc., providing regulatory acti…

• 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, enabling continued marketing under…

• 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 · 2011-10-12
  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.

• FDA approval · 2011-05-11
  FDA Approved: NITROFURANTOIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for nitrofurantoin from Amneal Pharmaceuticals NY LLC, granting marketing approval for this generic pr…

• FDA approval · 2010-10-14
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Nitrofurantoin submitted by Rising Pharma Holdings, Inc. The approval involves a supplement …

• FDA approval · 2008-05-30
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for nitrofurantoin from Rising Pharma Holdings, Inc. The action likely updates labeling or indic…