Pyelonephritis

• FDA approval · 2025-10-22
  FDA Approved: CONTEPO — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Contepo (fosfomycin disodium) from Meitheal Pharmaceuticals as a new intravenous antibiotic under NDA212271 for the treatme…

• EMA approval · 2024-03-22
  EMA Authorised: Exblifep (cefepime dihydrochloride monohydrate;Enmetazobactam) — Advanz Pharma Limited

  Exblifep has been authorised for multiple infections including urinary tract infections, pyelonephritis, healthcare-associated pneumonia, an…

• FDA approval · 2023-02-10
  FDA Approved: ZEMDRI (PLAZOMICIN) — Supplemental Application (Cipla Therapeutics Inc.)

  FDA approved a supplemental application for ZemdrI (plazomicin) from Cipla Therapeutics Inc.

• FDA approval · 2020-07-15
  FDA Approved: ZEMDRI (PLAZOMICIN) — Supplemental Application (Cipla Therapeutics Inc.)

  FDA approved a supplemental application for ZemdrI (plazomicin) submitted by Cipla Therapeutics Inc.

• FDA approval · 2020-04-22
  FDA Approved: LEVOFLOXACIN — Original Application (Gland Pharma Limited)

  FDA approved an original application for levofloxacin from Gland Pharma Limited, authorizing a generic version of the antibiotic.

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• FDA approval · 2019-11-14
  FDA Approved: FETROJA — Original Application (Shionogi Inc.)

  The FDA approves Fetroja (cefiderocol sulfate tosylate) from Shionogi in an Original New Drug Application for the treatment of complicated u…

• FDA approval · 2018-06-25
  FDA Approved: ZEMDRI (PLAZOMICIN) — Original Application (Cipla Therapeutics Inc.)

  FDA approved ZemdrI (plazomicin) under an original NDA from Cipla Therapeutics Inc. as a new antibiotic for complicated urinary tract infect…

• FDA approval · 2017-08-29
  FDA Approved: VABOMERE — Original Application (Melinta Therapeutics, LLC)

  FDA approved VABOMERE (meropenem-vaborbactam) from Melinta Therapeutics as an original application.

• FDA approval · 2016-04-12
  FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…

• 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 · 2013-06-05
  FDA Approved: LEVOFLOXACIN — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's Original Application for levofloxacin (generic), granting clearance for a generic version of th…

• FDA approval · 2012-03-30
  FDA Approved: LEVOFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for Levofloxacin, a generic antibiotic, submitted by Chartwell RX, LLC. The approval enables a generic version…

• FDA approval · 2007-08-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's amoxicillin/clavulanate potassium as an Original Application (ANDA), granting approval for a generic antibiotic pr…