Bacterial Sinusitis

• 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…

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• 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…

• CLINICAL_TRIALS trial_result · 2008-03-27
  Clinical Trial Update: Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis [Phase 3]

  A Phase 3 comparative trial evaluating the safety and efficacy of Clarithromycin Extended-Release Tablets versus Amoxicillin-Clavulanate for…

• CLINICAL_TRIALS trial_result · 2008-03-27
  Clinical Trial Update: Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis [Phase 4]

  A Phase 4 clinical trial assessing the safety and efficacy of cefdinir plus levofloxacin for acute bacterial sinusitis has completed.

• 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.

• FDA approval · 2007-10-17
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Clarithromycin submitted by Sandoz Inc, granting a supplemental approval for the product.

• FDA approval · 2007-09-07
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for cefdinir, updating the approved labeling for the product.

• FDA approval · 2007-08-20
  FDA Approved: CLARITHROMYCIN — Original Application (Chartwell RX, LLC.)

  FDA approved a generic version of clarithromycin from Chartwell RX, LLC through an Original Abbreviated New Drug Application (ANDA).

• 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…

• FDA approval · 2007-05-04
  FDA Approved: CEFDINIR — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's original application for CEFDINIR (cefdinir), a generic cephalosporin antibiotic.