Pneumonia

• FDA approval · 2012-06-01
  FDA Approved: CEFIXIME — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' cefixime product under NDA203195 as a generic oral cephalosporin antibiotic.

• FDA approval · 2012-04-09
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original ANDA for vancomycin hydrochloride from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., enabling a g…

• FDA approval · 2011-10-26
  FDA Approved: MEROPENEM — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original application for Meropenem as an injectable generic antibiotic.

• 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 · 2010-10-21
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Hospira, Inc)

  FDA approved Hospira's piperacillin/tazobactam combination under an original ANDA application, providing a generic version of the antibiotic…

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• 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 · 2010-06-07
  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 · 2009-12-22
  FDA Approved: AMPICILLIN AND SULBACTAM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma's Ampicillin and Sulbactam as an Original Application (AND A065406), a generic antibiotic combining ampicillin with sulba…

• 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…

• 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 · 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.

• FDA approval · 2007-03-26
  FDA Approved: AMOXICILLIN — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for amoxicillin, making a generic amoxicillin product available. The approval supports its us…

• 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…

• FDA approval · 2006-05-19
  FDA Approved: CEFDINIR — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin's generic cefdinir (CEFDINIR) under an Original Application (ANDA065264), providing a new generic cephalosporin option.