FDA.reportPublic FDA data

Application 076354

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0722TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0722TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0722TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0724TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0724TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
0378-0724TizanidinetizanidineMylan Pharmaceuticals Inc.ANDACurrent
43353-914TizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-914TizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-914TizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-946TizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-946TizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-998TizanidinetizanidineMylan Institutional Inc.ANDACurrent
55154-5068TizanidinetizanidineCardinal HealthANDACurrent
55154-5068TizanidinetizanidineCardinal HealthANDACurrent