Otitis Media

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2007-11-09
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s generic amoxicillin and clavulanate potassium under an Original Application.

• 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 · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)

  FDA approved a supplemental application for Cephalexin submitted by AVKARE, indicating an approved modification to this product's label or a…

• FDA approval · 2007-09-27
  FDA Approved: CEPHALEXIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cephalexin from Teva Pharmaceuticals USA, Inc., representing an approved modification to the exi…

• 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 · 2007-08-13
  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 · 2007-07-25
  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 · 2007-05-09
  FDA Approved: CEFDINIR — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's cefdinir product CEFDINIR under an Original Application (ANDA). This generic antibiotic is approved for common infection…

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

  FDA approved Sandoz's original ANDA for 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.