FDA.reportPublic FDA data

Application 077797

Type
ANDA
Sponsor
PRINSTON INC

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
0615-3520Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7528Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33261-377Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
43547-399Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSolco Healthcare U.S., LLCANDACurrent
43547-399Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSolco Healthcare U.S., LLCANDACurrent
43547-400Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSolco Healthcare U.S., LLCANDACurrent
43547-400Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSolco Healthcare U.S., LLCANDACurrent
45865-801Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloridemedsource pharmaceuticalsANDACurrent
50090-0375Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0377Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0378Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0969Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4420Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4946Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4946Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5256Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5256Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50436-0400Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideUnit Dose ServicesANDACurrent
51655-442CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
52959-042Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideH. J Harkins Company IncANDACurrent
55154-8143Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideCardinal HealthANDACurrent
55700-229Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-599Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-599Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-599Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-599Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-599Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-696Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideQuality Care Products, LLANDACurrent
55700-696Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-696Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-696Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-696Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
60429-876Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-876Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideGolden State Medical SupplyANDACurrent
60760-399Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-417Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-418Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-537CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-901CYCLOBENZAPRINE HCLPrilosec 40mg TabsDIRECTRXANDACurrent
61919-901CYCLOBENZAPRINE HCLPrilosec 40mg TabsDirect_RxANDACurrent
61919-901CYCLOBENZAPRINE HCLPrilosec 40mg TabsDirect_RxANDACurrent
61919-901CYCLOBENZAPRINE HCLPrilosec 40mg TabsDirect_RxANDACurrent
61919-901CYCLOBENZAPRINE HCLCYCLOBENZAPRINE HCLDIRECTRXANDACurrent
61919-901CYCLOBENZAPRINE HCLCYCLOBENZAPRINE HCLDirect_RxANDACurrent
61919-901CYCLOBENZAPRINE HCLCYCLOBENZAPRINE HCLDirect_RxANDACurrent
63629-1209Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1209Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1210Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1210Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1211Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1211Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1212Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1212Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1213Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-1213Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-8983Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9297Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
63739-531Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMcKesson CorporationANDACurrent
63739-531Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-531Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
67046-142Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochlorideContract Pharmacy Services-PAANDACurrent
67296-0053Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug Inc.ANDACurrent
67296-1208Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1208Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1524Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1524Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1524Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent