| ZINC SULFATE |
219585 |
001 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
No
|
No
|
2025/05/01
|
2025/05/01
|
ASPIRO |
Prescription |
| ZINC SULFATE |
219585 |
002 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
No
|
No
|
2025/05/01
|
2025/05/01
|
ASPIRO |
Prescription |
| ZINC SULFATE |
219585 |
003 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
No
|
No
|
2025/05/01
|
2025/05/01
|
ASPIRO |
Prescription |
| ZINC SULFATE |
217624 |
001 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 10MG BASE/10ML (EQ 1MG BASE/ML) |
No
|
No
|
2025/06/10
|
2025/06/10
|
RK PHARMA |
Prescription |
| ZINC SULFATE |
217624 |
002 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 25MG BASE/5ML (EQ 5MG BASE/ML) |
No
|
No
|
2025/06/10
|
2025/06/10
|
RK PHARMA |
Prescription |
| ZINC SULFATE |
217624 |
003 |
ANDA |
ZINC SULFATE |
SOLUTION;INTRAVENOUS |
EQ 30MG BASE/10ML (EQ 3MG BASE/ML) |
No
|
No
|
2025/06/10
|
2025/06/10
|
RK PHARMA |
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) |