Skin and Soft Tissue Infections

• FDA approval · 2010-12-20
  FDA Approved: CEPHALEXIN — Original Application (AvPAK)

  FDA approved the original application for Cephalexin (generic) from AvPAK under ANDA090836.

• FDA approval · 2010-06-07
  FDA Approved: CEFUROXIME AXETIL — Original Application (Golden State Medical Supply, Inc.)

  FDA approved an original application for cefuroxime axetil from Golden State Medical Supply, Inc. for use as an oral antibiotic (ANDA).

• FDA approval · 2009-06-18
  FDA Approved: CEFTRIAXONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for ceftriaxone sodium (ceftriaxone) from Baxter Healthcare Company, authorizing changes to the appr…

• FDA approval · 2009-02-02
  FDA Approved: AMOXICILLIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for amoxicillin from Teva Pharmaceuticals USA, Inc., resulting in updated labeling and specification…

• FDA approval · 2008-12-30
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for vancomycin hydrochloride from Mylan Institutional LLC, marking the approval of a generic injectabl…

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• FDA approval · 2008-09-18
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Clarithromycin from Sandoz Inc, marking regulatory clearance for changes to this generic ant…

• FDA approval · 2008-01-16
  FDA Approved: CEFPROZIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for cefprozil from Lupin Pharmaceuticals, Inc., resulting in updated labeling under the supplemental…

• FDA approval · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)

  FDA approved a supplemental application for Cephalexin submitted by AVKARE, indicating an approved modification to this product's label or a…

• FDA approval · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cephalexin from Teva Pharmaceuticals USA, Inc., representing an approved modification to the exi…

• FDA approval · 2007-08-20
  FDA Approved: CLARITHROMYCIN — Original Application (Chartwell RX, LLC.)

  FDA approved a generic version of clarithromycin from Chartwell RX, LLC through an Original Abbreviated New Drug Application (ANDA).

• FDA approval · 2007-07-25
  FDA Approved: CEPHALEXIN — Original Application (Chartwell RX, LLC)

  FDA approved an Original Application for generic Cephalexin by Chartwell RX, LLC, adding a generic option for this antibiotic.

• FDA approval · 2007-04-26
  FDA Approved: ZYVOX — Supplemental Application (Hp Halden Pharma AS)

  The FDA approved a supplemental application for Zyvox (linezolid) submitted by Hp Halden Pharma AS.