Pharyngitis

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

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

• FDA approval · 2009-03-04
  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 · 2008-09-18
  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…

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• 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 · 2008-06-12
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA has approved a supplemental application for cefdinir (Teva), updating the labeling for the product. This action confirms a labeling-rela…

• FDA approval · 2008-06-11
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CEFDINIR (cefdinir) from Lupin Pharmaceuticals, indicating an expanded approval for this antibio…

• 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 · 2008-01-07
  FDA Approved: CEFDINIR — Original Application (BluePoint Laboratories)

  FDA approves an Abbreviated New Drug Application for cefdinir from BluePoint Laboratories, indicating the availability of a generic cefdinir…

• FDA approval · 2007-12-14
  FDA Approved: CEFDINIR — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic cefdinir (CEFDINIR) from Aurobindo Pharma Limited under an Original Application (ANDA) for acute otitis media, acute …

• 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 · 2007-09-07
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for cefdinir, updating the approved labeling for the product.

• 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 · 2007-05-07
  FDA Approved: CEFDINIR — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for CEFDINIR, a generic cefdinir product, authorizing continued/expanded ma…

• FDA approval · 2007-05-04
  FDA Approved: CEFDINIR — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's original application for CEFDINIR (cefdinir), a generic cephalosporin antibiotic.

• 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 · 2006-06-19
  FDA Approved: AMOXICILLIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc. to market amoxicillin under an Original Application (ANDA). The approval covers a generic amoxic…

• 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.