Bacterial Vaginosis

• FDA approval · 2021-03-05
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Metronidazole submitted by Baxter Healthcare Corporation.

• 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 · 2019-08-14
  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 · 2019-07-29
  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 · 2019-07-02
  FDA Approved: METRONIDAZOLE VAGINAL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved METRONIDAZOLE VAGINAL as an original generic application (ANDA) to manufacture a metronidazole vaginal product, with Padagis Is…

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• FDA approval · 2018-04-03
  FDA Approved: FLAGYL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Flagyl (metronidazole) from Pfizer Laboratories Div Pfizer Inc, resulting in changes to the …

• FDA approval · 2017-12-12
  FDA Approved: METRONIDAZOLE — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' generic metronidazole under an Original Application (ANDA209794).

• FDA approval · 2017-12-04
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Metronidazole from Baxter Healthcare Corporation, typically reflecting labeling updates or o…

• FDA approval · 2017-09-15
  FDA Approved: SOLOSEC — Original Application (Evofem Inc.)

  FDA approved SOLOSEC (secnidazole) under Evofem Inc.'s original NDA for the treatment of bacterial vaginosis.

• FDA approval · 2017-09-05
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for METRONIDAZOLE from Aurobindo Pharma Limited (ANDA 203974).

• FDA approval · 2016-03-01
  FDA Approved: CLINDESSE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for Clindesse (clindamycin phosphate) submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2015-05-29
  FDA Approved: METRONIDAZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for Metronidazole, granting approval for a generic metronidazole product. This …

• FDA approval · 2014-12-14
  FDA Approved: NUVESSA — Supplemental Application (Exeltis USA, Inc.)

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

• FDA approval · 2014-09-22
  FDA Approved: CLINDESSE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Clindesse (clindamycin phosphate) submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2014-03-24
  FDA Approved: NUVESSA — Original Application (Exeltis USA, Inc.)

  FDA approved NUVESSA (metronidazole) under an Original Application from Exeltis USA, Inc., branding a new product for the treatment of bacte…

• FDA approval · 2012-03-28
  FDA Approved: METRONIDAZOLE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for metronidazole filed by Taro Pharmaceuticals U.S.A., Inc. (ANDA077819).

• 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 · 2010-12-15
  FDA Approved: CLINDESSE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for CLINDESSE (clindamycin phosphate) submitted by Padagis Israel Pharmaceuticals Ltd.

• 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 · 2009-08-06
  FDA Approved: METRONIDAZOLE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's supplemental application for metronidazole under NDA 018657.

• FDA approval · 2009-06-23
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for a generic Metronidazole product.

• FDA approval · 2009-03-13
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original ANDA from Alembic Pharmaceuticals Limited for a generic metronidazole product.

• FDA approval · 2007-12-19
  FDA Approved: METRONIDAZOLE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' original Abbreviated New Drug Application for metronidazole, enabling a generic version of this antimi…

• 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…

• 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).