Amebic Liver Abscess

• 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 · 2021-09-03
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for Metronidazole, enabling a generic version of the antibiotic/antiprotozoal.

• 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 · 2012-03-28
  FDA Approved: METRONIDAZOLE — Supplemental Application (AMICI PHARMA INC)

  The FDA approved a supplemental application for metronidazole submitted by Amici Pharma Inc, resulting in updated labeling related to its in…

• FDA approval · 2007-06-27
  FDA Approved: METRONIDAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Metronidazole from Chartwell RX, LLC (ANDA number 076522).

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