Urinary Tract Infection

• FDA approval · 2010-11-29
  FDA Approved: CEFAZOLIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Cefazolin (cefazolin sodium) from Fresenius Kabi USA, LLC, updating an already approved prod…

• FDA approval · 2010-10-27
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

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

• 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 · 2009-06-18
  FDA Approved: CEFTRIAXONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for ceftriaxone sodium (ceftriaxone) from Baxter Healthcare Company, authorizing changes to the appr…

• FDA approval · 2009-04-15
  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. The action represents …

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• FDA approval · 2009-04-15
  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 · 2009-03-05
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Alvogen Inc.)

  The FDA approved a supplemental application for nitrofurantoin macrocrystals from Alvogen, signaling regulatory approval of a change to the …

• FDA approval · 2009-03-05
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Amoxicillin and Clavulanate Potassium, a generic antibiotic (…

• 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 · 2009-02-06
  FDA Approved: NITROFURANTOIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for nitrofurantoin submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2009-02-02
  FDA Approved: AMOXICILLIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for amoxicillin from Teva Pharmaceuticals USA, Inc., resulting in updated labeling and specification…

• FDA approval · 2008-09-22
  FDA Approved: CEPHALEXIN — Supplemental Application (AMELLA PHARMA, LLC)

  FDA approved a supplemental application for Cephalexin from Amella Pharma, LLC.

• FDA approval · 2008-06-16
  FDA Approved: CEFPODOXIME PROXETIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for cefpodoxime proxetil from Aurobindo Pharma Limited, marking a regulatory action on this generic …

• 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…

• FDA approval · 2008-01-16
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Nitrofurantoin Macrocrystals from Amneal Pharmaceuticals of New York LLC. This update confir…

• FDA approval · 2008-01-16
  FDA Approved: NITROFURANTOIN MACROCRYSTALS — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• FDA approval · 2007-11-09
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s generic amoxicillin and clavulanate potassium under an Original Application.

• FDA approval · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)

  FDA approved a supplemental application for Cephalexin submitted by AVKARE, indicating an approved modification to this product's label or a…

• FDA approval · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cephalexin from Teva Pharmaceuticals USA, Inc., representing an approved modification to the exi…

• FDA approval · 2007-07-25
  FDA Approved: CEPHALEXIN — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application for generic Cephalexin by Chartwell RX, LLC, adding a generic option for this antibiotic.

• FDA approval · 2007-07-13
  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 · 2007-06-27
  FDA Approved: NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for nitrofurantoin monohydrate/macrocrystalline by Alvogen Inc., indicating a regulatory action rela…

• FDA approval · 2007-03-26
  FDA Approved: AMOXICILLIN — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for amoxicillin, making a generic amoxicillin product available. The approval supports its us…

• FDA approval · 2006-06-19
  FDA Approved: AMOXICILLIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc. to market amoxicillin under an Original Application (ANDA). The approval covers a generic amoxic…