美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ELLA"
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
MELLARIL 011808 003 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 006 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 009 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 011 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 012 NDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 015 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 016 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 017 NDA THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL 011808 018 NDA THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1962/03/15 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
ASELLACRIN 10 017726 001 NDA SOMATROPIN INJECTABLE;INJECTION 10 IU/VIAL No No 1976/07/30 Approved Prior to Jan 1, 1982 SERONO Discontinued
ASELLACRIN 2 017726 002 NDA SOMATROPIN INJECTABLE;INJECTION 2 IU/VIAL No No 1976/07/30 1983/07/21 SERONO Discontinued
MELLARIL-S 017923 001 NDA THIORIDAZINE SUSPENSION;ORAL EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1978/10/18 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
MELLARIL-S 017923 002 NDA THIORIDAZINE SUSPENSION;ORAL EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1978/10/18 Approved Prior to Jan 1, 1982 NOVARTIS Discontinued
ACTIVELLA 020907 001 NDA ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Yes Yes 1998/11/18 1998/11/18 AMNEAL PHARMS LLC Prescription
ACTIVELLA 020907 002 NDA ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG Yes No 1998/11/18 2006/12/28 AMNEAL PHARMS LLC Prescription
ACTIVELLA 021103 001 NDA ESTRADIOL; NORETHINDRONE ACETATE TABLET; ORAL 1MG/0.5MG No 2000/04/11 NOVO NORDISK Prescription
ACTIVELLA 022001 001 NDA ESTRADIOL; NORETHINDRONE ACETATE TABLET; ORAL 1MG/0.5MG No 2006/12/29 NOVO NORDISK INC Prescription
SAVELLA 022256 001 NDA MILNACIPRAN HYDROCHLORIDE TABLET;ORAL 12.5MG Yes No 2009/01/14 2009/01/14 ALLERGAN SALES LLC Prescription
SAVELLA 022256 002 NDA MILNACIPRAN HYDROCHLORIDE TABLET;ORAL 25MG Yes No 2009/01/14 2009/01/14 ALLERGAN SALES LLC Prescription
SAVELLA 022256 003 NDA MILNACIPRAN HYDROCHLORIDE TABLET;ORAL 50MG Yes Yes 2009/01/14 2009/01/14 ALLERGAN SALES LLC Prescription
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