FDA.reportPublic FDA data

Application 074796

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1160Guanfacineguanfacine HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1190Guanfacineguanfacine HydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
60429-861Guanfacineguanfacine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-862Guanfacineguanfacine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
70518-0268Guanfacineguanfacine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0268Guanfacineguanfacine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0790Guanfacineguanfacine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0790Guanfacineguanfacine HydrochlorideREMEDYREPACK INC.ANDACurrent