Amoebiasis

• 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 · 2021-12-15
  FDA Approved: TINDAMAX — Supplemental Application (Mission Pharmacal Company)

  FDA approved a supplemental application for TINDAMAX (tinidazole) from Mission Pharmacal Company.

• FDA approval · 2020-05-26
  FDA Approved: TINDAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for tinidazole from Rising Pharma Holdings, Inc.

• 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 · 2015-08-04
  FDA Approved: TINIDAZOLE — Original Application (Edenbridge Pharmaceuticals LLC.)

  FDA approves Edenbridge Pharmaceuticals LLC's original ANDA for tinidazole (generic tinidazole), authorizing a generic version of the antibi…

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• FDA approval · 2013-10-09
  FDA Approved: TINDAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic tinidazole product under Rising Pharma Holdings' original ANDA, enabling broader access to tinidazole for protozoal i…

• FDA approval · 2012-04-30
  FDA Approved: TINIDAZOLE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved tinidazole from Lupin Pharmaceuticals via an original application (ANDA 202044). The approval covers indications including giar…

• 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.