FDA.reportPublic FDA data

Application 072668

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL20MGNoYes
002TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL5MGNoNo
003TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0055Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0055Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0055Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0055Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0221Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0221Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0221Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0221Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0715Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0715Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0715Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-0715Timolol Maleatetimolol maleateMylan Pharmaceuticals Inc.ANDACurrent
63629-7167Timolol Maleatetimolol maleateBryant Ranch PrepackANDACurrent
63629-7167Timolol Maleatetimolol maleateBryant Ranch PrepackANDACurrent
69189-0496Timolol Maleatetimolol maleateAvera McKennan HospitalANDACurrent