Staphylococcal Infections

• FDA approval · 2022-11-15
  FDA Approved: MUPIROCIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for mupirocin from Amneal Pharmaceuticals NY LLC (generic mupirocin).

• FDA approval · 2020-07-27
  FDA Approved: NAFCILLIN — Supplemental Application (Athenex Pharmaceutical Division, LLC.)

  FDA approved a supplemental application for Nafcillin (Nafcillin Sodium) by Athenex Pharmaceutical Division, LLC. The action constitutes a s…

• FDA approval · 2020-07-27
  FDA Approved: OXACILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's Oxacillin sodium as an original-application (ANDA) generic antibiotic. It is indicated for infections…

• FDA approval · 2018-07-10
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for vancomycin hydrochloride from Mylan Institutional LLC, confirming its use for treating serious infe…

• FDA approval · 2018-04-05
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Nafcillin submitted by Baxter Healthcare Corporation under NDA 050655.

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• FDA approval · 2016-03-31
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Eugia US LLC)

  The FDA approved a generic vancomycin hydrochloride for injection under an original application from Eugia US LLC. This adds a generic IV op…

• FDA approval · 2015-04-03
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Nafcillin from Baxter Healthcare Corporation, authorizing changes to the existing NDA. This appr…

• FDA approval · 2011-06-30
  FDA Approved: NAFCILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Nafcillin sodium (NAFCILLIN SODIUM) as a generic injectable antibiotic from Fresenius Kabi USA, LL…

• FDA approval · 2008-12-30
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for vancomycin hydrochloride from Mylan Institutional LLC, marking the approval of a generic injectabl…