剂型或给药途径 TABLET;ORAL 规格 40MG 治疗等效代码 参比药物 否 批准日期 申请机构 LUPIN LTD 8 药品名称 LURASIDONE HYDROCHLORIDE 申请号 208031 产品号 003 活性成分 LURASIDONE HYDROCHLORIDE 市场状态 暂时批准 剂型或给药途径 TABLET;ORAL 规格 60MG 治疗等效代码 参比药物 否 批准日期 申请机构 LUPIN LTD 9...
TABLET;ORAL - 120MG,TABLET;ORAL - 20MG,TABLET;ORAL - 40MG,TABLET;ORAL - 60MG,TABLET;ORAL - 80MG RELATED EXCIPIENT COMPANIES 1Rochem International Inc,15SPI Pharma,4Faran Shimi Pharmaceutical,7Gangwal Healthcare,1Pfanstiehl,4Anhui Sunhere Pharmaceutical Excipients Co.,Ltd,1BASF,1DFE Pharma,2Ga...
Lurasidone hydrochloride tablet has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily [see Clinical Studies (14.2)]. The maximum recommended ...
LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry®and carnauba wax. Additionally,...
企业名称 NORTHSTAR HLTHCARE 申请类型 ANDA--仿制药申请 产品信息 商品名 TEcode 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效 批准历史,通知信,药品说明书,综述等审批信息 批准日期 申请类型 申请提交号 审查批准结论
Table 1: LATUDA Tablet Presentations Storage And Handling LATUDAtablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L...
Table 1: LATUDA Tablet Presentations Storage And Handling LATUDAtablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L...
Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and ...