Postoperative Ocular Inflammation and Pain

• FDA approval · 2025-05-20
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original application for Loteprednol etabonate ophthalmic drops from Amneal Pharmaceuticals NY LLC, providing a generic…

• FDA approval · 2021-02-10
  FDA Approved: LOTEPREDNOL ETABONATE — Original Application (ARMAS PHARMACEUTICALS INC.)

  FDA approved the original application for Loteprednol etabonate ophthalmic suspension from Armas Pharmaceuticals, establishing the generic c…

• FDA approval · 2016-04-11
  FDA Approved: DIFLUPREDNATE OPHTHALMIC — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for difluprednate ophthalmic submitted by Sandoz Inc, resulting in updated labeling for the product.

• FDA approval · 2012-09-28
  FDA Approved: LOTEMAX — Original Application (Bausch & Lomb Incorporated)

  FDA approved Lotemax (loteprednol etabonate) ophthalmic suspension under NDA 202872 for the treatment of postoperative ocular inflammation a…