Otitis Externa

• 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 · 2025-09-26
  FDA Approved: CLOTIC (CLOTRIMAZOLE) OTIC SOLUTION — Original Application (Carwin Pharmaceutical Associates, LLC)

  The FDA approved CLOTIC, a clotrimazole otic solution, under an original NDA from Carwin Pharmaceutical Associates for the treatment of fung…

• FDA approval · 2025-07-09
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)

  The FDA approved a supplemental application for Ciprofloxacin and Dexamethasone from Dr. Reddy's Laboratories, granting regulatory approval …

• FDA approval · 2024-12-03
  FDA Approved: HYDROCORTISONE AND ACETIC ACID — Supplemental Application (Saptalis Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Hydrocortisone and Acetic Acid Otic from Saptalis Pharmaceuticals, LLC. This action authoriz…

• FDA approval · 2024-11-05
  FDA Approved: CIPROFLOXACIN OTIC — Original Application (Genus Lifesciences)

  FDA approved Ciprofloxacin Otic under Genus Lifesciences' original application as a generic antibiotic ear drop for otitis externa.

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• 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 · 2022-07-14
  FDA Approved: OFLOXACIN — Original Application (Lifestar Pharma LLC)

  FDA approved the original application for OFLOXACIN OTIC from Lifestar Pharma LLC under ANDA 216130.

• 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 · 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 · 2020-08-10
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approves the original application for ciprofloxacin and dexamethasone by Dr. Reddy's Laboratories as a generic product.

• FDA approval · 2019-08-30
  FDA Approved: OFLOXACIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal’s generic Ofloxacin Otic (OFLOXACIN OTIC) under an Original Application for the treatment of otitis externa.

• FDA approval · 2019-03-15
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION — Supplemental Application (Rising Pharma Holdings, Inc.)

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

• FDA approval · 2019-02-21
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for ciprofloxacin and dexamethasone from Sandoz, updating the approval status for this otic suspensi…

• FDA approval · 2019-01-05
  FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Cortisporin TC (colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone a…

• FDA approval · 2018-04-11
  FDA Approved: FLAC OTIC OIL — Original Application (Patrin Pharma, Inc.)

  The FDA approved Patrin Pharma's original ANDA for FLAC OTIC OIL, a fluocinolone acetonide otic corticosteroid product intended to treat inf…

• 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 · 2017-03-20
  FDA Approved: CIPRO HC — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for CIPRO HC (ciprofloxacin hydrochloride and hydrocortisone) submitted by Sandoz Inc.

• FDA approval · 2016-03-29
  FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Cortisporin TC, a four-ingredient otic preparation, under Endo USA, Inc.

• 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 · 2008-08-06
  FDA Approved: OFLOXACIN OTIC — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for OFLOXACIN OTIC from Apotex Corp., updating the product's labeling and/or approval scope.

• FDA approval · 2007-09-28
  FDA Approved: OFLOXACIN OTIC — Original Application (Apotex Corp.)

  FDA approved Apotex Corp's generic OFLOXACIN OTIC as an original ANDA.

• FDA approval · 2006-07-03
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE — Supplemental Application (Bausch & Lomb Incoporated)

  The FDA approved a supplemental application from Bausch & Lomb for Neomycin and Polymyxin B Sulates and Hydrocortisone, signaling an update …