Bacterial Vaginosis

• FDA approval · 2026-02-13
  FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved the original ANDA for metronidazole from Viona Pharmaceuticals Inc, enabling a generic version of the antibiotic to be marketed…

• FDA approval · 2024-12-31
  FDA Approved: METRONIDAZOLE VAGINAL — Original Application (Saptalis Pharmaceuticals LLC)

  FDA approved Metronidazole Vaginal through an Original Application by Saptalis Pharmaceuticals LLC (a generic metronidazole vaginal product)…

• 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 · 2024-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for metronidazole from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals Inc. under an ANDA.

• 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 · 2024-06-18
  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 · 2024-03-18
  FDA Approved: METRONIDAZOLE VAGINAL GEL — Original Application (Encube Ethicals, Inc.)

  The FDA approved an original application for METRONIDAZOLE VAGINAL GEL 1.3% from Encube Ethicals, Inc. This marks approval of a generic vers…

• FDA approval · 2023-11-03
  FDA Approved: CLINDESSE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for CLINDESSE (clindamycin phosphate) filed by Padagis Israel Pharmaceuticals Ltd. The action pe…

• 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 · 2023-06-16
  FDA Approved: METRONIDAZOLE VAGINAL GEL, 0.75% — Original Application (Encube Ethicals, Inc.)

  FDA approved Encube Ethicals' generic Metronidazole vaginal gel 0.75% (ANDA 215610).

• FDA approval · 2023-03-06
  FDA Approved: XACIATO — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for XACIATO, a clindamycin phosphate vaginal gel from Organon LLC.

• 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…

• FDA approval · 2022-03-16
  FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for METRONIDAZOLE submitted by Prasco Laboratories.

• FDA approval · 2022-02-25
  FDA Approved: NUVESSA — Supplemental Application (Exeltis USA, Inc.)

  The FDA approved a supplemental application for NUVESSA (metronidazole) from Exeltis USA, Inc.

• FDA approval · 2022-01-26
  FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)

  The FDA approved a supplemental application for SoLOSEC (secnidazole) from Evofem Inc., expanding the product's labeling/indication.

• 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 · 2021-12-15
  FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)

  FDA approved a supplemental application for SOLOSEC (secnidazole) submitted by Evofem Inc. The action represents an approved supplemental su…

• FDA approval · 2021-12-07
  FDA Approved: XACIATO — Original Application (Organon LLC)

  FDA approved XACIATO (clindamycin phosphate) from Organon LLC under an Original Application; it is a vaginal antibiotic for the treatment of…

• FDA approval · 2021-12-06
  FDA Approved: NUVESSA — Supplemental Application (Exeltis USA, Inc.)

  The FDA approved a supplemental application for NUVESSA (metronidazole) from Exeltis USA, Inc.

• 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 · 2021-09-03
  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 · 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 · 2021-08-18
  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 · 2021-06-14
  FDA Approved: SOLOSEC — Supplemental Application (Evofem Inc.)

  The FDA approved a supplemental application for SOLOSEC (secnidazole) submitted by Evofem Inc.