Application 212639

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 2% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-519Dorzolamide HydrochlorideDorzolamide HydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent
62332-519Dorzolamide HydrochlorideDorzolamide HydrochlorideAlembic Pharmaceuticals Inc.ANDACurrent