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Results For "ophthalmic"

110 News Found

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion
Drug Approval | December 17, 2024

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery


Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%
News | November 28, 2024

Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%

Glenmark's Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz


Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)
Drug Approval | October 04, 2024

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)

Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP
News | August 19, 2024

Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP

This addition highlights our commitment to meeting market needs and providing high-quality over the-counter solutions for our customers


Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | August 17, 2024

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.


Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
News | August 06, 2024

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity


Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | July 24, 2024

Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

The product is bioequivalent and therapeutically equivalent to the reference listed drug


Lupin and Huons Sign agreement for commercialization of cyclosporine ophthalmic nanoemulsion in Mexico
News | July 22, 2024

Lupin and Huons Sign agreement for commercialization of cyclosporine ophthalmic nanoemulsion in Mexico

Cyclosporine Ophthalmic Nanoemulsion is a preservative-free Nanoemulsion that has been approved in South Korea, Peru and several countries in the Middle East for treatment of dry eye syndrome


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product