Anaerobic Bacterial Infections

• 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 · 2024-06-18
  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 · 2024-01-09
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metronidazole from Aurobindo Pharma Limited.

• FDA approval · 2023-10-17
  FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Metronidazole filed by Sun Pharmaceutical Industries, Inc., updating the drug’s labeling as …

• FDA approval · 2022-03-31
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metronidazole from Aurobindo Pharma Limited, indicating a supplemental approval for this generic…

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• 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 · 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 · 2010-05-05
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for Metronidazole from Alembic Pharmaceuticals Limited (generic approval).

• FDA approval · 2007-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for metronidazole (ANDA070027), authorizing changes to the approved product through a supplemen…