| 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 |