FDA.reportPublic FDA data

Application 205295

Type
ANDA
Sponsor
FDC LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 2% BASE;EQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55545-1007Dorzolamide and TimololDorzolamide Hydrochloride and Timolol MaleateFDC LimitedANDACurrent
69315-305Dorzolamide and TimololDorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionLeading Pharma, LLCANDACurrent
69315-305Dorzolamide and TimololDorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionLeading Pharma, LLCANDACurrent