FDA.reportPublic FDA data

Application 078048

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-200Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10702-006Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideKVK-TECH, Inc.ANDACurrent
10702-007Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideKVK-TECH, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-494Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-516Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-516Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-516Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-516Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-917Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2761Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50436-0006Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
50436-0006Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
52959-846CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEH. J. Harkins Company Inc.ANDACurrent
53002-0520Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0520Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-527Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-527Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-527Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-094Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-094Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-094Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-094Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
67046-117Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-1343Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1343Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1343Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1998Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68084-753Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmerican Health PackagingANDACurrent
68084-753Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmerican Health PackagingANDACurrent
68084-753Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmerican Health PackagingANDACurrent
68788-9508Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-667Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-667Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70938-003Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride1 Veterans HealthANDACurrent
70938-003Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride1 Veterans HealthANDACurrent
71335-0128Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0128Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71610-016Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-016Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-016Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-188Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent