美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=CYCLOBENZAPRINE HYDROCHLORIDE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
CYCLOBENZAPRINE HYDROCHLORIDE 077797 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2007/02/28 2007/02/28 PRINSTON INC Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078218 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2008/04/18 2008/04/18 CHARTWELL RX Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078218 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2008/04/18 2015/06/19 CHARTWELL RX Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078218 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No 2008/04/18 2020/11/03 CHARTWELL RX Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078722 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2008/05/12 2008/05/12 SUN PHARM INDS LTD Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078722 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No 2008/05/12 2008/05/12 SUN PHARM INDS LTD Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078722 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2008/05/12 2008/05/12 SUN PHARM INDS LTD Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078643 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2008/09/26 2008/09/26 AUROBINDO PHARMA Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078643 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2008/09/26 2008/09/26 AUROBINDO PHARMA Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 090478 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2010/07/23 2010/07/23 INVAGEN PHARMS Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 090478 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2010/07/23 2010/07/23 INVAGEN PHARMS Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078048 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2011/02/28 2011/02/28 KVK TECH Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 078048 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No 2011/02/28 2011/02/28 KVK TECH Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 091281 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 15MG No No 2013/01/31 2013/01/31 TWI PHARMS INC Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 091281 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 30MG No No 2013/01/31 2013/01/31 TWI PHARMS INC Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 090864 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL 15MG No No 2013/07/26 (TA) -- PAR PHARM INC None (Tentative Approval)
CYCLOBENZAPRINE HYDROCHLORIDE 090864 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL 30MG No No 2013/07/26 (TA) -- PAR PHARM INC None (Tentative Approval)
CYCLOBENZAPRINE HYDROCHLORIDE 208170 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No 2017/05/31 2017/05/31 RUBICON Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 208170 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No 2017/05/31 2017/05/31 RUBICON Prescription
CYCLOBENZAPRINE HYDROCHLORIDE 208170 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No Yes 2017/05/31 2017/05/31 RUBICON Prescription
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