Bronchitis

• FDA approval · 2014-12-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…

• FDA approval · 2014-11-08
  FDA Approved: LEVOFLOXACIN — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for Levofloxacin submitted by Sagent Pharmaceuticals, approving changes to the generic labeling …

• FDA approval · 2013-11-22
  FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for cefixime. This action updates the cefixime NDA, potentially expanding i…

• FDA approval · 2013-03-29
  FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for cefixime from Lupin Pharmaceuticals, Inc. to modify/extend its labeling and/or approval.

• FDA approval · 2012-12-18
  FDA Approved: AZITHROMYCIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for azithromycin submitted by Teva Pharmaceuticals USA, Inc.

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• 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 · 2011-10-07
  FDA Approved: COMBIVENT RESPIMAT — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved Combivent Respimat (ipratropium bromide and albuterol) in an original application for relief of bronchospasm associated with ch…

• FDA approval · 2010-07-13
  FDA Approved: THEOPHYLLINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Theophylline from an Original Application; Theophylline is a bronchodilator used to treat symptoms of obstructive ai…

• 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 · 2010-02-16
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).

• FDA approval · 2009-04-03
  FDA Approved: MUCINEX DM MAXIMUM STRENGTH — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex DM Maximum Strength (guaifenesin and dextromethorphan hydrobromide) submitted by RB Heal…

• FDA approval · 2008-07-23
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cefdinir (CEFDINIR). The approval authorizes changes to the cefdi…

• 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 · 2008-03-10
  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 · 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 · 2007-09-06
  FDA Approved: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE — Supplemental Application (WALGREEN COMPANY)

  FDA approved Walgreens' supplemental application for Guaifenesin and Pseudoephedrine Hydrochloride.

• 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…

• FDA approval · 2006-08-23
  FDA Approved: MUCINEX — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Mucinex (guaifenesin) from RB Health (US) LLC, indicating FDA action on a supplemental submissio…

• 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.