Otitis Media

• 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 · 2013-05-22
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ciprofloxacin and dexamethasone (Ciprodex) from Sandoz Inc, expanding the product label.

• 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 · 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 · 2012-07-25
  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 · 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 · 2012-02-17
  FDA Approved: CEFACLOR — Original Application (Azorian Pharma, LLC)

  The FDA approved Azorian Pharma, LLC's original application for Cefaclor (generic) for treating susceptible bacterial infections including r…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for amoxicillin and clavulanate potassium, authorizing the marketing of thi…

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

  The FDA approved a supplemental application for Cephalexin from AvKare.

• FDA approval · 2011-01-27
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for amoxicillin and clavulanate potassium (Hikma Pharmaceuticals USA Inc.), updating the product…

• 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 · 2010-12-20
  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 · 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 · 2009-05-14
  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 · 2009-03-04
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for Clarithromycin from Sandoz Inc, granting approval to a generic version under an ANDA.

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

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

• 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 · 2008-07-23
  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 …