FDA.reportPublic FDA data

Application 077259

Type
ANDA
Sponsor
FDC LTD

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
45865-121TIMOLOL MALEATEtimolol maleateMedsource PharmaceuticalsANDACurrent
50090-1852TIMOLOL MALEATEtimolol maleateA-S Medication SolutionsANDACurrent
50090-5091TIMOLOL MALEATEtimolol maleateA-S Medication SolutionsANDACurrent
55545-1000TIMOLOL MALEATEtimolol maleateFDC LimitedANDACurrent
55545-1001TIMOLOL MALEATEtimolol maleateFDC LimitedANDACurrent
64980-513TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
64980-513TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
64980-513TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
64980-514TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
64980-514TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
64980-514TIMOLOL MALEATEtimolol maleateRising Pharmaceuticals, Inc.ANDACurrent
67877-229Timolol MaleateTimolol MaleateAscend Laboratories, LLCANDACurrent
68071-1558TIMOLOL MALEATEtimolol maleateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2354TIMOLOL MALEATEtimolol maleateREMEDYREPACK INC.ANDACurrent
76519-1163TIMOLOL MALEATETIMOLOL MALEATEH.J. Harkins Company, Inc.ANDACurrent