Skin and Soft Tissue 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 · 2019-08-16
  FDA Approved: MEROPENEM — Original Application (WG Critical Care, LLC)

  FDA approved WG Critical Care, LLC's original ANDA for Meropenem, providing a generic version of the carbapenem antibiotic.

• 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 · 2019-05-28
  FDA Approved: LINEZOLID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for LINEZOLID submitted by Sun Pharmaceutical Industries, Inc. The approval relates to changes to th…

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• FDA approval · 2018-04-05
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Nafcillin submitted by Baxter Healthcare Corporation under NDA 050655.

• FDA approval · 2018-02-21
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (SAMSON MEDICAL TECHNOLOGIES LLC)

  The FDA approved Samson Medical Technologies LLC's supplemental application for vancomycin hydrochloride, a generic antibiotic, under an app…

• FDA approval · 2017-07-14
  FDA Approved: NAFCILLIN — Supplemental Application (Baxter Healthcare Corporation)

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

• FDA approval · 2016-08-04
  FDA Approved: LINEZOLID — Original Application (Eugia US LLC)

  FDA approves a generic version of linezolid (ANDA 206917) for Eugia US LLC, expanding access to this antibiotic.

• 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 · 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 · 2016-04-12
  FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…

• FDA approval · 2016-03-31
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Eugia US LLC)

  The FDA approved a generic vancomycin hydrochloride for injection under an original application from Eugia US LLC. This adds a generic IV op…

• FDA approval · 2016-03-15
  FDA Approved: LINEZOLID — Original Application (Hp Halden Pharma AS)

  FDA approved a generic version of the antibiotic linezolid (Hp Halden Pharma AS) under an original ANDA submission.

• 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 · 2015-12-21
  FDA Approved: LINEZOLID — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic LINEZOLID (linezolid) under an original application (ANDA), enabling market entry of a g…

• FDA approval · 2015-09-28
  FDA Approved: CLARITHROMYCIN — Original Application (Solaris Pharma Corporation)

  FDA approved an Original Application (ANDA) for Clarithromycin from Solaris Pharma Corporation, establishing a generic version of clarithrom…

• FDA approval · 2015-07-16
  FDA Approved: LINEZOLID — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc.'s Original Application (ANDA) for LINEZOLID, enabling a generic linezolid product to be marketed.

• FDA approval · 2015-06-03
  FDA Approved: LINEZOLID — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approves Hikma Pharmaceuticals USA Inc.'s generic LINEZOLID (linezolid) under an Original Abbreviated New Drug Application.

• FDA approval · 2013-05-03
  FDA Approved: LINEZOLID — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for LINEZOLID submitted by Mylan Pharmaceuticals Inc. The action reflects an approved modification t…

• FDA approval · 2012-07-25
  FDA Approved: CLARITHROMYCIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic clarithromycin product under an original ANDA from Rising Pharma Holdings, Inc.

• FDA approval · 2011-06-30
  FDA Approved: NAFCILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Nafcillin sodium (NAFCILLIN SODIUM) as a generic injectable antibiotic from Fresenius Kabi USA, LL…

• FDA approval · 2011-05-04
  FDA Approved: CEPHALEXIN — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Cephalexin from AvKARE under ANDA 062713, authorizing continued manufacture and marketing of a C…

• FDA approval · 2011-04-20
  FDA Approved: NAFCILLIN — Original Application (Athenex Pharmaceutical Division, LLC.)

  FDA approves the original application for Nafcillin (nafcillin sodium) as a generic antibiotic from Athenex Pharmaceutical Division, LLC.

• FDA approval · 2011-02-22
  FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)

  The FDA approved a supplemental application for Cephalexin from AvKare.