FDA.reportPublic FDA data

Application 203395

Type
ANDA
Sponsor
HI TECH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-249bromfenacbromfenacAkornANDACurrent
50383-249bromfenacbromfenacHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-249bromfenacbromfenacHi-Tech Pharmacal Co., Inc.ANDACurrent