FDA.reportPublic FDA data

Application 213324

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-413Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-413Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-413Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-414Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-414Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-414Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-5711Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5712Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5713Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5756Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5756Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5772Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideA-S Medication SolutionsANDACurrent
53002-0523Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-925Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
55700-926Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideQuality Care Products, LLCANDACurrent
68071-2471Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3251Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1961Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1961Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1962Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1962Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideBryant Ranch PrepackANDACurrent
72189-280CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirectRxANDACurrent
72189-280CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirectRxANDACurrent
76420-256Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideAsclemed USA, Inc.ANDACurrent
80425-0155FlexirilCyclobenzaprine 5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0155FlexirilCyclobenzaprine 5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0155Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0155Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent