Lower Respiratory Tract Infection

• FDA approval · 2024-08-22
  FDA Approved: AMPICILLIN AND SULBACTAM — Supplemental Application (Eugia US LLC)

  FDA granted supplemental approval for Ampicillin and Sulbactam (AMPICILLIN AND SULBACTAM) submitted by Eugia US LLC.

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…

• FDA approval · 2021-04-16
  FDA Approved: AZACTAM — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for AZACTAM (aztreonam) from E.R. Squibb & Sons, L.L.C. The approval updates the product labeling fo…

• FDA approval · 2014-03-05
  FDA Approved: CIPROFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved the original application for ciprofloxacin (generic) by Chartwell RX, LLC.

• 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…

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• 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 · 2011-10-26
  FDA Approved: CEFOTETAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for cefotetan from Hikma Pharmaceuticals USA Inc., authorizing a generic cefotetan product.

• 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 · 2007-10-31
  FDA Approved: AMPICILLIN AND SULBACTAM — Supplemental Application (Hospira, Inc)

  FDA approved a supplemental application for ampicillin/sulbactam from Hospira for the existing product (Unasyn).