Otitis Media

• FDA approval · 2020-11-03
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ciprofloxacin and dexamethasone, an otic antibiotic/steroid combination. The submission was file…

• FDA approval · 2020-07-28
  FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)

  FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…

• FDA approval · 2020-06-03
  FDA Approved: AMOXICILLIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for amoxicillin submitted by Sandoz Inc.

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZITHROMYCIN from Lupin Pharmaceuticals, Inc., signaling an update to the product's regulatory a…

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN DIHYDRATE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for azithromycin dihydrate submitted by Precision Dose, Inc.

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• FDA approval · 2020-04-22
  FDA Approved: LEVOFLOXACIN — Original Application (Gland Pharma Limited)

  FDA approved an original application for levofloxacin from Gland Pharma Limited, authorizing a generic version of the antibiotic.

• FDA approval · 2020-03-09
  FDA Approved: CEFDINIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Cefdinir from Teva Pharmaceuticals USA, Inc., resulting in labeling updates for the product.

• FDA approval · 2020-03-09
  FDA Approved: CEFDINIR — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for CEFDINIR (cefdinir) from Aurobindo Pharma Limited, a generic cephalosporin antibiotic.

• FDA approval · 2020-02-11
  FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2020-01-28
  FDA Approved: AZITHROMYCIN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' original application for AZITHROMYCIN, granting a generic azithromycin product for the same indication…

• FDA approval · 2020-01-27
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Amoxicillin and clavulanate potassium by Sandoz Inc.

• FDA approval · 2020-01-23
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for azithromycin filed by Aurobindo Pharma Limited.

• FDA approval · 2019-12-19
  FDA Approved: CEFUROXIME AXETIL — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for cefuroxime axetil from Golden State Medical Supply, Inc., recognizing an update to this generic …

• FDA approval · 2019-04-19
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Amoxicillin and clavulanate potassium from Aurobindo Pharma Limited, a generic antibiotic product.

• FDA approval · 2018-12-07
  FDA Approved: AZITHROMYCIN — Original Application (Lannett Company, Inc.)

  FDA approves Lannett Company, Inc.'s original application for azithromycin (AZITHROMYCIN), a generic antibiotic.

• FDA approval · 2018-09-24
  FDA Approved: AZITHROMYCIN DIHYDRATE — Original Application (Precision Dose, Inc.)

  FDA approved azithromycin dihydrate as a generic drug under Original Application by Precision Dose, Inc., expanding access to this antibioti…

• FDA approval · 2018-07-05
  FDA Approved: AZITHROMYCIN — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic azithromycin product under an Original ANDA for Aurobindo Pharma Limited.

• FDA approval · 2017-12-19
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension from Rising Pharma Hold…

• FDA approval · 2017-05-15
  FDA Approved: CEFPROZIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Cefprozil submitted by Rising Pharma Holdings, Inc., resulting in an updated labeling for the pr…

• FDA approval · 2016-04-12
  FDA Approved: CEFUROXIME — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Cefuroxime, adding an additional approved use/formulation under t…

• FDA approval · 2015-09-28
  FDA Approved: CLARITHROMYCIN — Original Application (Solaris Pharma Corporation)

  FDA approved an Original Application (ANDA) for Clarithromycin from Solaris Pharma Corporation, establishing a generic version of clarithrom…

• FDA approval · 2015-07-27
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Chartwell RX, LLC.)

  FDA approved Chartwell RX, LLC.'s supplemental application for Clarithromycin (generic) under the ANDA process, resulting in approval of a g…

• FDA approval · 2015-07-01
  FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for clarithromycin from Sandoz Inc, indicating continued/expanded approval for generic use of the dr…

• 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 · 2014-09-26
  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. The supplement rel…