Pelvic Inflammatory Disease

• FDA approval · 2025-02-14
  FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for metronidazole from Alembic Pharmaceuticals Limited.

• 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 · 2024-06-13
  FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Ertapenem (ERTAPENEM) by Eugia US LLC. The action relates to a modification/expansion of the dru…

• FDA approval · 2024-05-01
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Amoxicillin and clavulanate potassium (amoxicillin-clavulanate) from Northstar RxLLC, authorizin…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-04-21
  FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)

  The FDA approved Viona Pharmaceuticals' original application for metronidazole, granting a generic version of the antibiotic/antiprotozoal.

• 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 · 2022-02-08
  FDA Approved: ERTAPENEM — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Apotex Corp to market ertapenem sodium (ERTAPENEM) as a generic antibiotic.

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

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

• FDA approval · 2020-09-09
  FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…

• 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 · 2020-05-01
  FDA Approved: AZITHROMYCIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZITHROMYCIN from Lupin Pharmaceuticals, Inc., signaling an update to the product's regulatory a…

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN DIHYDRATE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for azithromycin dihydrate submitted by Precision Dose, 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 · 2018-06-25
  FDA Approved: ERTAPENEM — Original Application (Eugia US LLC)

  The FDA approved an original application for ertapenem from Eugia US LLC, authorizing a generic version of the carbapenem antibiotic ertapen…

• 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 · 2016-06-29
  FDA Approved: CEFTRIAXONE SODIUM — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved the Original Application for ceftriaxone sodium from Qilu Pharmaceutical Co., Ltd., a broad-spectrum cephalosporin used to trea…

• FDA approval · 2012-12-18
  FDA Approved: AZITHROMYCIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for azithromycin submitted by Teva Pharmaceuticals USA, Inc.

• 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 · 2011-09-30
  FDA Approved: CLINDAMYCIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for CLINDAMYCIN PHOSPHATE (clindamycin), a generic antibiotic for treating suscept…

• 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.