| CARBIDOPA; LEODOPA |
210911 |
007 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
61.25MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
007 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
61.25MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
008 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
48.75MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
008 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
48.75MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
009 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
195MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
009 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
195MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
002 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
140MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
003 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
87.5MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
004 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
350MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
005 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
70MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
006 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
280MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
007 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
52.5MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219989 |
008 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
210MG |
No
|
No
|
2025/11/12
(TA)
|
--
|
SANDOZ INC |
None (Tentative Approval) |