FDA.reportPublic FDA data

Application 211029

Type
ANDA
Sponsor
GLAND PHARMA 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
68083-313BROMFENACBromfenacGland Pharma LimitedANDACurrent
72266-142BROMFENACBromfenacFosun Pharma USA Inc.ANDACurrent