| CUPRIC SULFATE |
019350 |
001 |
NDA |
CUPRIC SULFATE |
INJECTABLE;INJECTION |
EQ 0.4MG COPPER/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 |
| CUPRIC SULFATE |
216324 |
001 |
ANDA |
CUPRIC SULFATE |
INJECTABLE;INJECTION |
EQ 0.4MG COPPER/ML |
No
|
Yes
|
2022/12/16
|
2022/12/16
|
AM REGENT |
Prescription |
| CUPRIC SULFATE |
218745 |
001 |
ANDA |
CUPRIC SULFATE |
INJECTABLE;INJECTION |
EQ 0.4MG COPPER/ML |
No
|
No
|
2024/08/19
|
2024/08/19
|
APOTEX CORP |
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) |