FDA.reportPublic FDA data

Application 077563

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0057cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0179-0189cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
21695-036Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRebel DistributorsANDACurrent
42291-154Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvKAREANDACurrent
42291-154Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvKAREANDACurrent
50090-4024Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4024Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4026Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4105Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4105Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4205Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5326Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5326Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50436-9804Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
53808-1039cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
59746-177Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-211Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-735Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
63629-2424Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2424Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
67046-119cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideContract Pharmacy Services-PAANDACurrent
67296-1763Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1763Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
71610-379Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0017FlexerilCyclobenzaprine HCl 5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0017Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0017Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent