美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SELENIOUS ACID"
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
SELENIOUS ACID 209379 001 NDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) Yes Yes 2019/04/30 2019/04/30 AM REGENT Prescription
SELENIOUS ACID 209379 002 NDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) Yes Yes 2019/04/30 2021/01/25 AM REGENT Prescription
SELENIOUS ACID 209379 003 NDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) Yes Yes 2019/04/30 2021/08/30 AM REGENT Prescription
SELENIOUS ACID 218779 001 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) No No 2025/02/10 2025/02/10 FRESENIUS KABI USA Discontinued
SELENIOUS ACID 219547 001 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) No No 2025/02/20 2025/02/20 SUN PHARM Prescription
SELENIOUS ACID 219492 001 ANDA SELENIOUS ACID INJECTION;SOLUTION 600MCG/10ML No No 2025/04/28 (TA) -- STERISCIENCE PTE. LIMITED None (Tentative Approval)
SELENIOUS ACID 219633 001 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) No No 2025/06/11 2025/06/11 ASPIRO Prescription
SELENIOUS ACID 219633 002 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) No No 2025/06/11 2025/06/11 ASPIRO Prescription
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)
SELENIOUS ACID 219629 001 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) No No 2025/07/08 2025/07/08 GLAND Prescription
SELENIOUS ACID 218661 001 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) No No 2025/07/21 2025/07/21 CIPLA Prescription
SELENIOUS ACID 218661 002 ANDA SELENIOUS ACID SOLUTION;INTRAVENOUS EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) No No 2025/07/21 2025/07/21 CIPLA Prescription
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