FDA.reportPublic FDA data

Application 071611

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3420Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3421Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3422Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0440-1350Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7350Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideActavis Pharma, Inc.ANDACurrent
0904-7809Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMajor PharmaceuticalsANDACurrent
10544-072Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-830Fexmidcyclobenzaprine hydrochlorideRebel Distributors CorpANDACurrent
42708-081Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQPharma IncANDACurrent
42708-081Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQPharma IncANDACurrent
42708-106Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQPharma IncANDACurrent
42708-106Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQPharma IncANDACurrent
50090-2862Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3163Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3167Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3290Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3329Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3728Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5895Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5896Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5897Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5900Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50436-0950FexmidCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
51655-440CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
53002-0522Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53149-4842CyclobenzaprineCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
53149-4850FexmidCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
53149-4850FexmidCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
53149-4851FexmidCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
55154-7884Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCardinal HealthANDACurrent
55154-7884Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCardinal HealthANDACurrent
55700-726FexmidCyclobenzaprine HydrochlorideQuality Care Products, LLCANDACurrent
57237-266CyclobenzaprineCyclobenzaprine HydrochlorideCitron Pharma LLCANDACurrent
57237-266CyclobenzaprineCyclobenzaprine HydrochlorideRising Health, LLCANDACurrent
60429-052Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-052Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63187-011Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-011Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-380Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-380Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63629-7803FexmidCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7803FexmidCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7803FexmidCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
66336-581Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDispensing Solutions, Inc.ANDACurrent
67296-0007Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67544-251Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-251Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2596Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4502Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4502Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4502Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4826Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4826Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68387-500Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEKeltman Pharmaceuticals Inc.ANDACurrent
68387-502Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEKeltman Pharmaceuticals Inc.ANDACurrent
69176-300Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTMIG IncANDACurrent
70199-014FexmidCyclobenzaprine HydrochlorideCasper Pharma LLCANDACurrent
70518-0301Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-253Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-383Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-383Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-059FexmidCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-059FexmidCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-059FexmidCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-059FexmidCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-059FexmidCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-897CyclobenzaprineCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-897CyclobenzaprineCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71335-1253FexmidCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
76420-268Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAsclemed USA, Inc.ANDACurrent