FDA.reportPublic FDA data

Application 078218

Type
ANDA
Sponsor
ORIT LABS LLC

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
10544-159Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-037Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRebel DistributorsANDACurrent
33261-033Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33358-097Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRxChange Co.ANDACurrent
50090-2605Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2644Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2678Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2737Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
53746-540CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-540CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-540CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-540CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-541CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-541CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-541CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53746-541CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
53808-0948Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
55289-403Comfort Pac With CyclobenzaprineCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-567Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-0541Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideClinical Solutions WholesaleANDACurrent
58517-080CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENew Horizon Rx Group, LLCANDACurrent
62332-646CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-646CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-647CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-647CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-649CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-649CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
63187-157Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-157Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63629-1339Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1339Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7653Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7653Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-7960CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7960CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
64205-541Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideReadyMedsANDACurrent
65162-540Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-540Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-540Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-541Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-541Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-541Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
67296-0447Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug Inc.ANDACurrent
69336-104Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSterling Knight Pharmaceuticals,LLCANDACurrent
71335-1089CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1089CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1178CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1178CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent