美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=OVRAL"
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
OVRAL 016672 001 NDA ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-21 0.05MG;0.5MG No No 1968/04/16 Approved Prior to Jan 1, 1982 WYETH PHARMS Discontinued
OVRAL-28 016806 001 NDA ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.05MG;0.5MG No No 1968/11/26 Approved Prior to Jan 1, 1982 WYETH PHARMS Discontinued
LO/OVRAL 017612 001 NDA ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-21 0.03MG;0.3MG Yes No 1975/03/17 Approved Prior to Jan 1, 1982 CADENCE HEALTH Discontinued
LO/OVRAL-28 017802 001 NDA ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1976/03/16 Approved Prior to Jan 1, 1982 WYETH PHARMS Discontinued
LO/OVRAL FE 018206 001 NDA ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE TABLET;ORAL 0.03MG,0.3MG;75MG No No 1979/07/26 -- CADENCE HEALTH Prescription
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