FDA.reportPublic FDA data

Application 090604

Type
ANDA
Sponsor
SANDOZ INC

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
61314-030Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateSandoz IncANDACurrent
61314-030Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateSandoz IncANDACurrent
61314-030Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateSandoz IncANDACurrent
61314-030Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateSandoz IncANDACurrent