Intra-abdominal Infections

• FDA approval · 2019-08-20
  FDA Approved: CLINDAMYCIN HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for clindamycin hydrochloride from Chartwell RX, LLC.

• 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 · 2019-06-12
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.

• FDA approval · 2018-08-10
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Shandong Anxin Pharmaceutical Co., Ltd.)

  FDA approved the original application for a generic Piperacillin and Tazobactam combination from Shandong Anxin Pharmaceutical Co., Ltd., ex…

• FDA approval · 2018-05-18
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original generic application for Piperacillin and tazobactam (Piperacillin and tazobactam), authorizi…

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• 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 · 2016-05-12
  FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the supplemental application for clindamycin phosphate (Padagis Israel Pharmaceuticals Ltd), reflecting approval of the supplem…

• FDA approval · 2016-01-21
  FDA Approved: CLEOCIN HYDROCHLORIDE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride) filed by Pharmacia & Upjohn Company LLC.

• FDA approval · 2015-12-07
  FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (WG Critical Care, LLC)

  FDA approved Ampicillin and Sulbactam from WG Critical Care, LLC under an Original Application (ANDA), making a generic antibiotic available…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…

• 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 · 2010-09-20
  FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (Eugia US LLC)

  FDA approved an original ANDA for Ampicillin and Sulbactam by Eugia US LLC, authorizing a generic version of the ampicillin-sulbactam antibi…

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

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

• FDA approval · 2009-03-05
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Amoxicillin and Clavulanate Potassium, a generic antibiotic (…

• 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 · 2007-08-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's amoxicillin/clavulanate potassium as an Original Application (ANDA), granting approval for a generic antibiotic pr…

• FDA approval · 2007-08-09
  FDA Approved: CEFOTETAN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Cefotetan disodium (generic) from Fresenius Kabi USA, LLC under an Original Application (ANDA). This approval covers the cephal…