FDA.reportPublic FDA data

Application 216533

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 0.25% BASENoNo
002TIMOLOL MALEATETIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-287Timolol Maleatetimolol maleateIngenus Pharmaceuticals, LLCANDACurrent
50742-287Timolol Maleatetimolol maleateIngenus Pharmaceuticals, LLCANDACurrent
50742-288Timolol Maleatetimolol maleateIngenus Pharmaceuticals, LLCANDACurrent
50742-288Timolol Maleatetimolol maleateIngenus Pharmaceuticals, LLCANDACurrent