美国FDA药品数据库-药物在线

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
MANGANESE SULFATE	019228	001	NDA	MANGANESE SULFATE	INJECTABLE;INJECTION	EQ 0.1MG MANGANESE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1987/05/05	1987/05/05	ABRAXIS PHARM	Discontinued
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	001	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	55UG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	002	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	0.3MG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	003	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	60UG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	004	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	3MG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	005	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	1000UG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	006	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	6UG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	219632	007	ANDA	ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID	INJECTION	3UG/1ML	No	No	2025/06/25 (TA)	--	GLAND PHARMA LIMITED	None (Tentative Approval)