Drug

Who makes dorzolamide hydrochloride and timolol maleate ophthalmic solution?

2 companies list dorzolamide hydrochloride and timolol maleate ophthalmic solution as a human prescription drug. Forms: solution; solution/ drops. Routes: ophthalmic.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing dorzolamide hydrochloride and timolol maleate ophthalmic solution

CompanyFormsApplicationNDCsRegistered sites
Alembic Pharmaceuticals LimitedIndiasolution/ dropsANDAANDA21309927
Leading Pharma, LLCUnited StatessolutionANDAANDA20529511
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Common questions

Who makes dorzolamide hydrochloride and timolol maleate ophthalmic solution?
2 companies list dorzolamide hydrochloride and timolol maleate ophthalmic solution as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Leading Pharma, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic dorzolamide hydrochloride and timolol maleate ophthalmic solution?
2 companies list dorzolamide hydrochloride and timolol maleate ophthalmic solution under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.