Skin and Skin Structure Infections

• FDA approval · 2015-07-27
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Chartwell RX, LLC.)

  FDA approved Chartwell RX, LLC.'s supplemental application for Clarithromycin (generic) under the ANDA process, resulting in approval of a g…

• FDA approval · 2015-07-01
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin from Sandoz Inc, indicating continued/expanded approval for generic use of the dr…

• FDA approval · 2015-06-18
  FDA Approved: LINEZOLID — Original Application (Hospira, Inc.)

  FDA approved Hospira's original application for linezolid, an antibiotic indicated for pneumonia and skin and skin structure infections.

• FDA approval · 2014-09-26
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc. The supplement rel…

• FDA approval · 2013-06-05
  FDA Approved: LEVOFLOXACIN — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare Corporation's Original Application for levofloxacin (generic), granting clearance for a generic version of th…

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• FDA approval · 2013-04-25
  FDA Approved: CEFADROXIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic cefadroxil product from Rising Pharma Holdings, Inc. (ANDA065349).

• FDA approval · 2012-03-30
  FDA Approved: LEVOFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved an original ANDA for Levofloxacin, a generic antibiotic, submitted by Chartwell RX, LLC. The approval enables a generic version…

• 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 · 2010-12-22
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…

• 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 · 2009-05-14
  FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) submitted by Sandoz Inc.

• 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 · 2008-09-22
  FDA Approved: CEPHALEXIN — Supplemental Application (AMELLA PHARMA, LLC)

  FDA approved a supplemental application for Cephalexin from Amella Pharma, LLC.

• FDA approval · 2008-06-16
  FDA Approved: CEFPODOXIME PROXETIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for cefpodoxime proxetil from Aurobindo Pharma Limited, marking a regulatory action on this generic …

• FDA approval · 2008-03-20
  FDA Approved: CEFEPIME — Original Application (Sagent Pharmaceuticals)

  FDA records the original approval of cefepime hydrochloride (cefepime) for Sagent Pharmaceuticals under an ANDA. The approval concerns a bro…

• FDA approval · 2008-03-10
  FDA Approved: CEFPROZIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Cefprozil from Teva Pharmaceuticals USA, Inc., updating labeling or indications for the anti…

• FDA approval · 2007-10-31
  FDA Approved: AMPICILLIN AND SULBACTAM — Supplemental Application (Hospira, Inc)

  FDA approved a supplemental application for ampicillin/sulbactam from Hospira for the existing product (Unasyn).

• FDA approval · 2007-10-17
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Clarithromycin submitted by Sandoz Inc, granting a supplemental approval for the product.

• 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 · 2007-04-06
  FDA Approved: CEFDINIR — Original Application (Sandoz Inc)

  FDA approved Sandoz's original ANDA for cefdinir, a generic cephalosporin antibiotic.

• FDA approval · 2007-01-30
  FDA Approved: CEFPROZIL — Original Application (Aurobindo Pharma Limited)

  The FDA approved the original application for cefprozil from Aurobindo Pharma Limited, making a generic cephalosporin antibiotic available i…