美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA021777"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
0093-1921-06 0093-1921 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20190304 N/A NDA AUTHORIZED GENERIC NDA021777 Teva Pharmaceuticals USA, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1921-06)
72189-362-60 72189-362 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCL ER Cyclobenzaprine HCL ER CAPSULE, EXTENDED RELEASE ORAL 20220725 N/A NDA NDA021777 Direct_Rx CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)
72189-389-60 72189-389 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCL ER Cyclobenzaprine HCL ER CAPSULE, EXTENDED RELEASE ORAL 20221109 N/A NDA AUTHORIZED GENERIC NDA021777 Direct_Rx CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-389-60)
80425-0292-2 80425-0292 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCL ER Cyclobenzaprine HCL CAPSULE, EXTENDED RELEASE ORAL 20230331 N/A NDA AUTHORIZED GENERIC NDA021777 Advanced Rx Pharmacy of Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2)
80425-0292-3 80425-0292 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCL ER Cyclobenzaprine HCL CAPSULE, EXTENDED RELEASE ORAL 20230331 N/A NDA AUTHORIZED GENERIC NDA021777 Advanced Rx Pharmacy of Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)
63459-701-60 63459-701 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071101 N/A NDA NDA021777 Cephalon, LLC CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60)
63459-700-60 63459-700 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071002 N/A NDA NDA021777 Cephalon, LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-700-60)
80425-0292-1 80425-0292 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCL ER Cyclobenzaprine HCL CAPSULE, EXTENDED RELEASE ORAL 20230331 N/A NDA AUTHORIZED GENERIC NDA021777 Advanced Rx Pharmacy of Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1)
0093-1920-06 0093-1920 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20190304 N/A NDA AUTHORIZED GENERIC NDA021777 Teva Pharmaceuticals USA, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1920-06)
0115-1436-13 0115-1436 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20190301 N/A NDA AUTHORIZED GENERIC NDA021777 Amneal Pharmaceuticals of New York LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13)
0115-1437-13 0115-1437 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20190301 N/A NDA AUTHORIZED GENERIC NDA021777 Amneal Pharmaceuticals of New York LLC CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1437-13)
55700-981-60 55700-981 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20220809 N/A NDA AUTHORIZED GENERIC NDA021777 Quality Care Products, LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-981-60)
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