Urinary Tract Infections

• FDA approval · 2025-08-21
  FDA Approved: MEROPENEM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Meropenem submitted by BluePoint Laboratories (ANDA205883), confirming approval of a supplementa…

• FDA approval · 2024-09-27
  FDA Approved: CEPHALEXIN — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for Cepalexin (cephalexin) from Ascend Laboratories, LLC, establishing a generic cephalexin product.

• FDA approval · 2024-09-27
  FDA Approved: CEPHALEXIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Cephalexin from Aurobindo Pharma Limited.

• FDA approval · 2024-03-14
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for doxycycline, a generic antibiotic, expanding the availability of doxycycline pr…

• FDA approval · 2023-10-31
  FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…

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• FDA approval · 2023-10-12
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Eugia US LLC)

  FDA approved the original abbreviated new drug application for piperacillin and tazobactam, a combination antibiotic manufactured by Eugia U…

• FDA approval · 2023-09-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)

  FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.

• FDA approval · 2019-12-19
  FDA Approved: CEFUROXIME AXETIL — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for cefuroxime axetil from Golden State Medical Supply, Inc., recognizing an update to this generic …

• FDA approval · 2019-08-16
  FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)

  FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.

• 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 · 2016-10-18
  FDA Approved: DOXYCYCLINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves a supplemental application for doxycycline from Lupin Pharmaceuticals, Inc. to modify/expand an existing generic product approv…

• FDA approval · 2014-09-26
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc. The supplement rel…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…

• FDA approval · 2011-05-04
  FDA Approved: CEPHALEXIN — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Cephalexin from AvKARE under ANDA 062713, authorizing continued manufacture and marketing of a C…

• FDA approval · 2010-02-16
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).