FDA.reportPublic FDA data

Application 208170

Type
ANDA
Sponsor
RUBICON

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-962CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridemedsource pharmaceuticalsANDACurrent
50090-4722CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4722CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4727CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4727CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4729CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4730CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
51655-427CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNorthwind PharmaceuticalsANDACurrent
52817-330CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-330CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-330CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-331CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-331CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-331CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-332CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-332CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
52817-332CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideTruPharma LLCANDACurrent
60760-363CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-365CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-365CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-366CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PANDACurrent
60760-366CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-366CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-366CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-366CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
63629-7939CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
67296-1621CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1621CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1621CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-2453CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2880CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4655CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceutuicals,Inc.ANDACurrent
68071-4655CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceutuicals,Inc.ANDACurrent
68071-4655CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceutuicals,Inc.ANDACurrent
68071-4935CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4935CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4951CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4951CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4951CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7445CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7445CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7445CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7445CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7536CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7536CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7536CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7536CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2611CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2611CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2611CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2611CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2788CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3356CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3356CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3415CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3415CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-221CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-221CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-442CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-442CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-065CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71205-065CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71205-065CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71205-356CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71205-356CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71205-356CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideProficient Rx LPANDACurrent
71335-1099CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1099CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1266CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1293CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1293CYCLOBENZAPRINE HYDROCHLORIDEcyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
72189-080CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
72189-080CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
72189-080CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
72189-080CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent