FDA.reportPublic FDA data

Application 074019

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PINDOLOLPINDOLOLTABLET;ORAL5MGNoNo
002PINDOLOLPINDOLOLTABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0052PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
0378-0052PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
0378-0052PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
0378-0127PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
0378-0127PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
0378-0127PindololpindololMylan Pharmaceuticals Inc.ANDACurrent
68151-1320PindololpindololCarilion Materials ManagementANDACurrent
68151-3005PindololpindololCarilion Materials ManagementANDACurrent