Sepsis

• FDA approval · 2024-05-01
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. for Piperacillin and Tazobactam (piperacillin/tazobactam).

• FDA approval · 2020-09-09
  FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…

• FDA approval · 2018-08-10
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Shandong Anxin Pharmaceutical Co., Ltd.)

  FDA approved the original application for a generic Piperacillin and Tazobactam combination from Shandong Anxin Pharmaceutical Co., Ltd., ex…

• 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…

• CLINICAL_TRIALS approval · 2018-03-08
  Clinical Trial Update: Expanded Access for LJPC-501

  La Jolla Pharmaceutical Company's LJPC-501 has been approved for marketing to treat catecholamine-resistant hypotension and distributive sho…

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• FDA approval · 2016-06-29
  FDA Approved: CEFTRIAXONE SODIUM — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved the Original Application for ceftriaxone sodium from Qilu Pharmaceutical Co., Ltd., a broad-spectrum cephalosporin used to trea…

• FDA approval · 2009-06-18
  FDA Approved: CEFTRIAXONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for ceftriaxone sodium (ceftriaxone) from Baxter Healthcare Company, authorizing changes to the appr…

• 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…