Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Bausch & Lomb Ophthalmic Diclofenac Sodium 0.1% Solution (ANDA078792)
The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.
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Regulatory Updates
Sep 27, 2026•1 min read
OCUCLEAR Ophthalmic Solution (0.025% OxyMetazoline HCl) Discontinued
OCUCLEAR ophthalmic drops containing 0.025% oxyMetazoline hydrochloride have been discontinued; FDA records show a series of approved manufacturing and labeling submissions from 1986 to 2001.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA079186 for Dorzolamide Hydrochloride Ophthalmic Solution
FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.
Regulatory Updates
Sep 24, 2026•1 min read
Chartwell Rx Receives FDA Approval for TRAVOPROST Ophthalmic Solution (ANDA091340)
The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approval History for Discontinued Ophthalmic Product Naphazoline Hydrochloride
The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Submissions for Discontinued Ophthalmic Product Isopto Cetamide
FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Sandoz OFLOXACIN Ophthalmic Solution (ANDA 076231)
The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
Sandoz Receives FDA Tentative Approval for Epinastine Hydrochloride Ophthalmic Solution (ANDA090950)
Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Bausch & Lomb OFLOXACIN Ophthalmic Solution (ANDA 076622)
The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ZADITOR Ophthalmic OTC Solution (ANDA077200)
FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA084144 for Proparacaine Hydrochloride Ophthalmic Solution
The FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution
The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.