FDA.reportPublic FDA data

Application 073144

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoYes
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0751Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0751Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0761Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0761Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0771Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0771Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
51079-644Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-644Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMylan Institutional Inc.ANDACurrent
51655-439Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideNorthwind PharmaceuticalsANDACurrent
55154-5571Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideCardinal HealthANDACurrent
55154-5571Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideCardinal HealthANDACurrent