Gynecologic 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 · 2024-06-18
  FDA Approved: METRONIDAZOLE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for metronidazole from Heritage Pharmaceuticals Inc. (d/b/a Avet Pharmaceuticals Inc.) to modify…

• 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).

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2023-01-27
  FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for ertapenem submitted by Eugia US LLC, authorizing changes to its approved labeling and/or ind…

• FDA approval · 2021-08-19
  FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for METRONIDAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., signaling an approved change…

• 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 · 2020-08-03
  FDA Approved: METRONIDAZOLE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic metronidazole (ANDA 212435), enabling a generic version of metronidazole for its establi…

• FDA approval · 2019-07-29
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Metronidazole from Aurobindo Pharma Limited, updating an existing generic product approval.

• FDA approval · 2019-02-25
  FDA Approved: METRONIDAZOLE — Original Application (Hospira, Inc.)

  FDA approves Hospira's original application for metronidazole (generic) for use in several anaerobic bacterial infections and protozoal infe…

• FDA approval · 2018-04-03
  FDA Approved: FLAGYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Flagyl (metronidazole) from Pfizer Laboratories Div Pfizer Inc, resulting in changes to the …

• FDA approval · 2017-12-12
  FDA Approved: METRONIDAZOLE — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' generic metronidazole under an Original Application (ANDA209794).

• FDA approval · 2017-12-04
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Metronidazole from Baxter Healthcare Corporation, typically reflecting labeling updates or o…

• 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 · 2015-05-29
  FDA Approved: METRONIDAZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for Metronidazole, granting approval for a generic metronidazole product. This …

• 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 · 2011-10-26
  FDA Approved: CEFOTETAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for cefotetan from Hikma Pharmaceuticals USA Inc., authorizing a generic cefotetan product.

• FDA approval · 2010-11-29
  FDA Approved: CEFAZOLIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Cefazolin (cefazolin sodium) from Fresenius Kabi USA, LLC, updating an already approved prod…

• FDA approval · 2010-10-21
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Hospira, Inc)

  FDA approved Hospira's piperacillin/tazobactam combination under an original ANDA application, providing a generic version of the antibiotic…

• FDA approval · 2010-03-12
  FDA Approved: CEFOXITIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved an original ANDA for cefoxitin by Hikma Pharmaceuticals USA, enabling a generic version of cefoxitin for its indicated infe…

• FDA approval · 2009-12-22
  FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma's Ampicillin and Sulbactam as an Original Application (AND A065406), a generic antibiotic combining ampicillin with sulba…

• FDA approval · 2009-08-06
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's supplemental application for metronidazole under NDA 018657.

• 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.