FDA.reportPublic FDA data

Application 210560

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BROMFENAC SODIUMBROMFENAC SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.09% ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-508Bromfenac Ophthalmic Solution 0.09%Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.ANDACurrent
62332-508Bromfenac Ophthalmic Solution 0.09%Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.ANDACurrent
62332-508Bromfenac Ophthalmic Solution 0.09%Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.ANDACurrent
62332-508Bromfenac Ophthalmic Solution 0.09%Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.ANDACurrent