Skin and Skin Structure Infection

• FDA approval · 2026-03-11
  FDA Approved: MEROPENEM — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Meropenem by Sandoz Inc, resulting in updated regulatory status for the product.

• FDA approval · 2025-06-23
  FDA Approved: MEROPENEM — Original Application (BROOKS STERISCIENCE LIMITED)

  FDA approved the original application for a generic meropenem product manufactured by Brooks SterisScience Limited.

• 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 · 2022-03-18
  FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Cefepime hydrochloride and dextrose from B. Braun Medical Inc.

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• 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 · 2021-02-16
  FDA Approved: PIPERACILLIN, TAZOBACTAM — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' generic Piperacillin-tazobactam for intravenous use under Original Application, enabling a generic vers…

• FDA approval · 2017-01-13
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Provepharm Inc.)

  FDA approved a generic combination product of piperacillin and tazobactam (piperacillin sodium and tazobactam sodium) from Provepharm Inc. u…

• 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 · 2014-03-05
  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: ERTAPENEM — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application for ertapenem (ertapenem sodium) filed by ENDO USA, Inc. This action updates regulatory status for t…

• 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: MEROPENEM — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original application for Meropenem as an injectable generic antibiotic.

• 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 · 2009-06-12
  FDA Approved: CEFOXITIN — Original Application (WG Critical Care, LLC)

  FDA approves Cefoxitin (cefoxitin) under an original application from WG Critical Care, LLC.