Gynecologic 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 · 2025-02-14
  FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for metronidazole from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-12-17
  FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Metronidazole from Sun Pharmaceutical Industries, Inc., resulting in continued approval of this …

• FDA approval · 2024-11-19
  FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to allow Zosyn in Galaxy containers (piperacillin/tazobactam), a packaging/formulation change from W…

• FDA approval · 2024-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metronidazole filed by Aurobindo Pharma Limited, authorizing the generic product under the suppl…

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• FDA approval · 2024-06-18
  FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Metronidazole from Alembic Pharmaceuticals Limited, granting approval for a generic version of t…

• FDA approval · 2024-05-01
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental ANDA for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) manufactured by Eugia US LLC.

• FDA label_change · 2023-11-22
  FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for metronidazole from Prasco Laboratories, indicating an updated labeling/approval for an additiona…

• 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 · 2021-12-15
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for metronidazole from Baxter Healthcare Corporation.

• FDA approval · 2021-10-14
  FDA Approved: METRONIDAZOLE — Original Application (Solaris Pharma Corporation)

  FDA approved Solaris Pharma Corporation's generic metronidazole (METRONIDAZOLE) under an original ANDA.

• FDA approval · 2021-08-18
  FDA Approved: METRONIDAZOLE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Metronidazole from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2021-07-29
  FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to allow Zosyn (piperacillin/tazobactam) to be supplied in Galaxy containers, by Wyeth Pharmaceutica…

• FDA approval · 2021-03-16
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) submitted by Eugia U…

• FDA label_change · 2020-05-26
  FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for ZOSYN in Galaxy containers, a packaging/labeling change for the piperacillin/tazobactam product.…

• FDA label_change · 2019-09-20
  FDA Approved: ERTAPENEM — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for ertapenem (ERTAPENEM SODIUM) submitted by ENDO USA, Inc.

• FDA approval · 2019-08-20
  FDA Approved: CLINDAMYCIN HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for clindamycin hydrochloride from Chartwell RX, LLC.

• FDA approval · 2019-08-14
  FDA Approved: METRONIDAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Metronidazole from Unichem Pharmaceuticals (USA), Inc., supporting a generic version under A…

• FDA approval · 2019-03-19
  FDA Approved: ERTAPENEM — Original Application (Apotex Corp)

  FDA approved Apotex Corp's original application for ertapenem sodium (ertapenem), a broad-spectrum carbapenem antibiotic, as a generic produ…

• 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 · 2018-05-18
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original generic application for Piperacillin and tazobactam (Piperacillin and tazobactam), authorizi…

• FDA approval · 2016-11-16
  FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved Metronidazole via an original application from Viona Pharmaceuticals Inc (ANDA206560). The approval confirms its use for anaero…

• FDA approval · 2016-05-12
  FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the supplemental application for clindamycin phosphate (Padagis Israel Pharmaceuticals Ltd), reflecting approval of the supplem…

• FDA approval · 2015-12-07
  FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (WG Critical Care, LLC)

  FDA approved Ampicillin and Sulbactam from WG Critical Care, LLC under an Original Application (ANDA), making a generic antibiotic available…