| CARBIDOPA, LEVODOPA AND ENTACAPONE |
214495 |
004 |
ANDA |
CARBIDOPA; ENTACAPONE; LEVODOPA |
TABLET;ORAL |
31.25MG;200MG;125MG |
No
|
No
|
2025/04/15
|
2025/04/15
|
MACLEODS PHARMS LTD |
Prescription |
| CARBIDOPA, LEVODOPA AND ENTACAPONE |
214495 |
005 |
ANDA |
CARBIDOPA; ENTACAPONE; LEVODOPA |
TABLET;ORAL |
37.5MG;200MG;150MG |
No
|
No
|
2025/04/15
|
2025/04/15
|
MACLEODS PHARMS LTD |
Prescription |
| CARBIDOPA, LEVODOPA AND ENTACAPONE |
214495 |
006 |
ANDA |
CARBIDOPA; ENTACAPONE; LEVODOPA |
TABLET;ORAL |
50MG;200MG;200MG |
No
|
No
|
2025/04/15
|
2025/04/15
|
MACLEODS PHARMS LTD |
Prescription |
| CARBIDOPA AND LEVODOPA |
219231 |
002 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
145MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
003 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
23.75 |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
004 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
95MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
005 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
245MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
006 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
61.25MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
007 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
48.75MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA AND LEVODOPA |
219231 |
008 |
ANDA |
CARBIDOPA, LEVODOPA |
CAPSULE, EXTENDED RELEASE |
195MG |
No
|
No
|
2025/06/13
(TA)
|
--
|
DR REDDYS LABS LTD |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
002 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
36.25MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
002 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
36.25MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
003 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
145MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
003 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
145MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
004 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
23.75MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
004 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
23.75MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
005 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
95MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
005 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
95MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
006 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
245MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |
| CARBIDOPA; LEODOPA |
210911 |
006 |
ANDA |
CARBIDOPA;LEODOPA |
CAPSULE, EXTENDED RELEASE |
245MG |
No
|
No
|
2025/08/08
(TA)
|
--
|
ZYDUS PHARMS USA INC |
None (Tentative Approval) |