Otitis Media

• FDA label_change · 2022-09-01
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for amoxicillin and clavulanate potassium submitted by Northstar RxLLC, resulting in updated labelin…

• FDA label_change · 2016-08-23
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Amoxicillin and clavulanate potassium submitted by Hikma Pharmaceuticals USA Inc., updating the …

• FDA label_change · 2015-03-16
  FDA Approved: AUGMENTIN ES-600 — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for AUGMENTIN ES-600 by USAntibiotics, LLC, updating the product labeling.

• FDA label_change · 2014-09-22
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for amoxicillin and clavulanate potassium filed by Northstar RxLLC, resulting in a label update …

• FDA label_change · 2013-12-06
  FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)

  FDA announces a supplemental application for Cortisporin TC, a four-ingredient otic preparation (colistin sulfate, neomycin sulfate, thonzon…

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• FDA label_change · 2010-04-27
  FDA Approved: CEFACLOR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cefaclor by Teva, updating the product labeling.

• FDA label_change · 2007-06-05
  FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) to modify the labeling.