Amebiasis

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

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

• FDA approval · 2016-11-16
  FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved Metronidazole via an original application from Viona Pharmaceuticals Inc (ANDA206560). The approval confirms its use for anaero…

• FDA approval · 2016-04-01
  FDA Approved: TINDAMAX — Supplemental Application (Mission Pharmacal Company)

  The FDA approved a supplemental application for TINDAMAX (tinidazole) from Mission Pharmacal Company, resulting in an updated labeling for t…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 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 · 2010-05-05
  FDA Approved: METRONIDAZOLE — Original Application (Alembic Pharmaceuticals Limited)

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

• FDA approval · 2009-06-23
  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 · 2007-12-14
  FDA Approved: HUMATIN — Original Application (Waylis Therapeutics LLC)

  The FDA approved Humatin (paromomycin sulfate) via an Original Application (AP) for Waylis Therapeutics LLC.

• 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).

• FDA approval · 2007-05-21
  FDA Approved: TINDAMAX — Supplemental Application (Mission Pharmacal Company)

  The FDA approved a supplemental application for TINDAMAX (tinidazole) submitted by Mission Pharmacal Company.