FDA.reportPublic FDA data

Application 204777

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 2.0% BASE;EQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol MaleateMicro Labs LimitedANDACurrent
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol MaleateMicro Labs LimitedANDACurrent
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol MaleateMicro Labs LimitedANDACurrent
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol MaleateMicro Labs LimitedANDACurrent
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol MaleateMicro Labs LimitedANDACurrent