Bacterial Sinusitis

• 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 · 2015-07-01
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin from Sandoz Inc, indicating continued/expanded approval for generic use of the dr…

• 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 · 2014-09-26
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc. The supplement rel…

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• 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…

• FDA approval · 2013-06-05
  FDA Approved: LEVOFLOXACIN — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's Original Application for levofloxacin (generic), granting clearance for a generic version of th…

• FDA approval · 2012-12-18
  FDA Approved: AZITHROMYCIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for azithromycin submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2012-07-25
  FDA Approved: CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic clarithromycin product under an original ANDA from Rising Pharma Holdings, Inc.

• FDA approval · 2012-03-30
  FDA Approved: LEVOFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for Levofloxacin, a generic antibiotic, submitted by Chartwell RX, LLC. The approval enables a generic version…

• FDA approval · 2012-02-17
  FDA Approved: CEFACLOR — Original Application (Azorian Pharma, LLC)

  The FDA approved Azorian Pharma, LLC's original application for Cefaclor (generic) for treating susceptible bacterial infections including r…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for amoxicillin and clavulanate potassium, authorizing the marketing of thi…

• FDA approval · 2011-01-27
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for amoxicillin and clavulanate potassium (Hikma Pharmaceuticals USA Inc.), updating the product…

• FDA approval · 2010-12-22
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…

• FDA approval · 2010-02-16
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).

• FDA approval · 2009-05-14
  FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) submitted by Sandoz Inc.

• 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 · 2009-03-04
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for Clarithromycin from Sandoz Inc, granting approval to a generic version under an ANDA.

• FDA approval · 2008-09-18
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Clarithromycin from Sandoz Inc, marking regulatory clearance for changes to this generic ant…

• FDA approval · 2008-07-23
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cefdinir (CEFDINIR). The approval authorizes changes to the cefdi…

• 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 · 2008-06-12
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA has approved a supplemental application for cefdinir (Teva), updating the labeling for the product. This action confirms a labeling-rela…

• FDA approval · 2007-12-14
  FDA Approved: CEFDINIR — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic cefdinir (CEFDINIR) from Aurobindo Pharma Limited under an Original Application (ANDA) for acute otitis media, acute …

• 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.