美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=RAZADYNE"
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
RAZADYNE 021169 001 NDA GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 4MG BASE Yes Yes 2001/02/28 2001/02/28 JANSSEN PHARMS Prescription
RAZADYNE 021169 002 NDA GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 8MG BASE Yes No 2001/02/28 2001/02/28 JANSSEN PHARMS Prescription
RAZADYNE 021169 003 NDA GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 12MG BASE Yes No 2001/02/28 2001/02/28 JANSSEN PHARMS Prescription
RAZADYNE 021224 001 NDA GALANTAMINE HYDROBROMIDE SOLUTION;ORAL 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 2001/06/22 2001/06/22 JANSSEN PHARMS Discontinued
RAZADYNE ER 021615 001 NDA GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 8MG BASE Yes Yes 2005/04/01 2005/04/01 JANSSEN PHARMS Prescription
RAZADYNE ER 021615 002 NDA GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 16MG BASE Yes No 2005/04/01 2005/04/01 JANSSEN PHARMS Prescription
RAZADYNE ER 021615 003 NDA GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE;ORAL EQ 24MG BASE Yes No 2005/04/01 2005/04/01 JANSSEN PHARMS Prescription
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