Bacterial Conjunctivitis

• FDA approval · 2025-12-10
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' original ANDA for Loteprednol etabonate and tobramycin ophthalmic suspension, a combination eye drop f…

• FDA approval · 2025-07-01
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Neomycin and Polymyxin B Sulfates and Hydrocortisone (neomycin sulfate, polymyxin B sulfate, hyd…

• FDA approval · 2025-04-07
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  Supplemental FDA approval for tobramycin and dexamethasone (Sandoz) as an ophthalmic combination product.

• FDA approval · 2025-01-27
  FDA Approved: MOXIFLOXACIN OPHTHALMIC SOLUTION — Original Application (Lifestar Pharma LLC)

  FDA approved a generic ophthalmic moxifloxacin solution from Lifestar Pharma LLC under an original ANDA for the treatment of bacterial conju…

• FDA approval · 2024-04-12
  FDA Approved: OFLOXACIN — Original Application (Leading Pharma, LLC)

  FDA approved the original application for OFLOXACIN ophthalmic solution 0.3% from Leading Pharma, LLC.

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• FDA approval · 2023-07-27
  FDA Approved: TOBRAMYCIN — Original Application (Micro Labs Limited)

  FDA approved Tobramycin ophthalmic solution from Micro Labs Limited under an Original Application.

• FDA approval · 2023-07-21
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Tobramycin and Dexamethasone (Bausch & Lomb Incorporated), authorizing changes to the product's …

• FDA approval · 2023-06-09
  FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (ARMAS PHARMACEUTICALS INC.)

  FDA approved an original ANDA for ciprofloxacin and dexamethasone from Armas Pharmaceuticals Inc., a generic antibiotic-steroid combination …

• FDA approval · 2022-02-11
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Original Application (Padagis US LLC)

  The FDA approved Padagis US LLC's generic Tobramycin and Dexamethasone ophthalmic suspension as an original ANDA for treatment of inflammati…

• FDA approval · 2021-11-03
  FDA Approved: GATIFLOXACIN — Original Application (Leading Pharma, LLC)

  FDA approved gatifloxacin ophthalmic solution 0.5% under an original ANDA from Leading Pharma, LLC for use in treating bacterial conjunctivi…

• FDA approval · 2021-10-25
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for the Loteprednol etabonate and tobramycin ophthalmic product from Bausch & Lomb Americas Inc.

• FDA approval · 2021-07-19
  FDA Approved: MOXIFLOXACIN OPHTHALMIC SOLUTION — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's supplemental application for moxifloxacin ophthalmic solution. This approval concerns the gen…

• FDA approval · 2021-05-14
  FDA Approved: NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE — Supplemental Application (Nordic Pharma, Inc.)

  FDA approved a supplemental application for NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE from Nordic Pharma, Inc., updating its a…

• FDA approval · 2021-05-14
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAXITROL (neomycin sulfate, polymyxin B sulfate and dexamethasone), updating labeling for this o…

• FDA approval · 2021-05-14
  FDA Approved: TOBREX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TOBREX (tobramycin) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2020-06-02
  FDA Approved: VIGAMOX — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) from Harrow Eye, LLC.

• FDA approval · 2020-05-11
  FDA Approved: VIGAMOX — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for VIGAMOX (moxifloxacin hydrochloride) filed by Harrow Eye, LLC. This represents a supplemental ap…

• FDA approval · 2020-04-24
  FDA Approved: TOBRADEX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TOBRADEX (tobramycin and dexamethasone) to update the ophthalmic label for inflammatory and infe…

• FDA approval · 2020-04-24
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Tobramycin and Dexamethasone from Sandoz, updating the existing NDA for this ophthalmic anti…

• FDA approval · 2020-03-30
  FDA Approved: MOXIFLOXACIN OPHTHALMIC SOLUTION — Original Application (Gland Pharma Limited)

  The FDA approved Gland Pharma Limited's MOXIFLOXACIN OPHTHALMIC SOLUTION as an original ANDA, providing a generic ophthalmic antibiotic for …

• FDA approval · 2020-02-07
  FDA Approved: NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Maxitrol (neomycin sulfate, polymyxin B sulfate, and dexamethasone) by Bausch & Lomb Incorporate…

• FDA approval · 2019-04-19
  FDA Approved: TOBRAMYCIN OPHTHALMIC SOLUTION — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Tobramycin Ophthalmic Solution from Alembic Pharmaceuticals Inc. under an original generic application (ANDA).

• FDA approval · 2019-02-13
  FDA Approved: MOXIFLOXACIN OPHTHALMIC SOLUTION — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' original application for MOXIFLOXACIN OPHTHALMIC SOLUTION, a generic ophthalmic antibiotic, for the tr…

• FDA approval · 2018-05-03
  FDA Approved: CIPROFLOXACIN HCL OPHTHALMIC — Original Application (Altaire Pharmaceuticals Inc.)

  FDA approved the original application for ciprofloxacin hydrochloride ophthalmic solution from Altaire Pharmaceuticals, granting generic app…

• FDA approval · 2017-12-18
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAXITROL (neomycin sulfate, polymyxin B sulfate and dexamethasone) from Novartis Pharmaceuticals…