FDA.reportPublic FDA data

Application 206703

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3972Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3972Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3973Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3973Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent