Otitis Media

• EMA approval · 2026-02-05
  EMA Authorised: Prevenar 13 (Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F) — Pfizer Europe MA EEIG

  EMA authorised Prevenar 13, a 13-valent pneumococcal conjugate vaccine, for immunization against pneumococcal infections in the EU. The vacc…

• FDA approval · 2026-01-06
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Ciprofloxacin hydrochloride and dexamethasone under an original application from Upsher-Smith Laboratories, for otic use to tre…

• FDA approval · 2025-02-21
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for sulfamethoxazole and trimethoprim, granting approval of a generic p…

• FDA approval · 2024-09-27
  FDA Approved: CEPHALEXIN — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for Cepalexin (cephalexin) from Ascend Laboratories, LLC, establishing a generic cephalexin product.

• FDA approval · 2024-09-27
  FDA Approved: CEPHALEXIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Cephalexin from Aurobindo Pharma Limited.

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• FDA approval · 2024-07-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Micro Labs Limited under ANDA217805.

• FDA approval · 2024-06-24
  FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for sulfamethoxazole and trimethoprim by Prasco Laboratories. This action confirms the approval of t…

• FDA approval · 2024-06-24
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium by Sandoz Inc to support changes to the approved gener…

• FDA approval · 2024-05-01
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Amoxicillin and clavulanate potassium (amoxicillin-clavulanate) from Northstar RxLLC, authorizin…

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…

• FDA approval · 2024-04-25
  FDA Approved: AMOXICILLIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amoxicillin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2024-04-24
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2024-04-09
  FDA Approved: CEFPROZIL — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for cefprozil from Ascend Laboratories, LLC, confirming it as a generic cephalosporin antibiotic.

• FDA approval · 2024-03-22
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved ciprofloxacin and dexamethasone otic suspension from Amneal as a generic (ANDA) product.

• FDA approval · 2023-12-11
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…

• FDA approval · 2023-10-31
  FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…

• FDA approval · 2023-09-15
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)

  FDA approves a generic amoxicillin/clavulanate potassium product under an Original Application by Devatis, Inc.

• FDA approval · 2023-09-13
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)

  FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.

• FDA approval · 2023-08-16
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for clarithromycin, marking a supplemental approval for this generic antibiotic. The acti…

• FDA approval · 2022-11-02
  FDA Approved: AMOXICILLIN — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for Amoxicillin submitted by USAntibiotics, LLC.

• FDA approval · 2022-11-02
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (USAntibiotics, LLC)

  FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium submitted by USAntibiotics, LLC.

• FDA approval · 2022-05-27
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ciprofloxacin and dexamethasone submitted by Sandoz Inc. The combination antibiotic/steroid is u…

• FDA approval · 2022-01-31
  FDA Approved: CLARITHROMYCIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic clarithromycin under Original Application ANDA210459. This expands access to clarithromycin as…

• FDA approval · 2022-01-12
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2021-02-19
  FDA Approved: CEFDINIR — Original Application (American Health Packaging)

  FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.