FDA.reportPublic FDA data

Application 207556

Type
ANDA
Sponsor
ELYSIUM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL5MGNoNo
002TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL10MGNoNo
003TIMOLOL MALEATETIMOLOL MALEATETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-618Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
13811-618Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
13811-619Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
13811-619Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
13811-620Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
13811-620Timolol MaleateTimolol MaleateTRIGEN LABORATORIES, LLCANDACurrent
73152-029Timolol MaleateTimolol MaleateAthem LLCANDACurrent
73152-029Timolol MaleateTimolol MaleateAthem LLCANDACurrent
73152-030Timolol MaleateTimolol MaleateAthem LLCANDACurrent
73152-030Timolol MaleateTimolol MaleateAthem LLCANDACurrent
73152-031Timolol MaleateTimolol MaleateAthem LLCANDACurrent
73152-031Timolol MaleateTimolol MaleateAthem LLCANDACurrent