美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ULTRAM"
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
ULTRAM 020281 001 NDA TRAMADOL HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 1995/03/03 JANSSEN PHARMS Discontinued
ULTRAM 020281 002 NDA TRAMADOL HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 1995/03/03 JANSSEN PHARMS Discontinued
ULTRAM ER 021692 001 NDA TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/09/08 2005/09/08 VALEANT PHARMS Discontinued
ULTRAM ER 021692 002 NDA TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/09/08 2005/09/08 VALEANT PHARMS Discontinued
ULTRAM ER 021692 003 NDA TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/09/08 2005/09/08 VALEANT PHARMS Discontinued
GRISEOFULVIN,ULTRAMICROSIZE 202545 001 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 125MG No No 2012/10/22 2012/10/22 SIGMAPHARM LABS LLC Prescription
GRISEOFULVIN,ULTRAMICROSIZE 202545 002 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 250MG No No 2012/10/22 2012/10/22 SIGMAPHARM LABS LLC Prescription
GRISEOFULVIN, ULTRAMICROSIZE 204371 001 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 125MG No No 2014/01/09 2014/01/09 MOUNTAIN Prescription
GRISEOFULVIN, ULTRAMICROSIZE 204371 002 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 250MG No Yes 2014/01/09 2014/01/09 MOUNTAIN Prescription
GRISEOFULVIN, ULTRAMICROSIZE 202805 001 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 125MG No No 2018/12/26 2018/12/26 SANDOZ Prescription
GRISEOFULVIN, ULTRAMICROSIZE 202805 002 ANDA GRISEOFULVIN, ULTRAMICROSIZE TABLET;ORAL 250MG No No 2018/12/26 2018/12/26 SANDOZ Prescription
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