| SUVOREXANT |
219386 |
001 |
ANDA |
SUVOREXANT |
TABLET |
10MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |
| SUVOREXANT |
219386 |
002 |
ANDA |
SUVOREXANT |
TABLET |
5MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |
| SUVOREXANT |
219386 |
003 |
ANDA |
SUVOREXANT |
TABLET |
40MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |
| SUVOREXANT |
219386 |
004 |
ANDA |
SUVOREXANT |
TABLET |
30MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |
| SUVOREXANT |
219386 |
005 |
ANDA |
SUVOREXANT |
TABLET |
20MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |
| SUVOREXANT |
219386 |
006 |
ANDA |
SUVOREXANT |
TABLET |
15MG |
No
|
No
|
2025/12/22
(TA)
|
--
|
HETERO LABS LTD UNIT III |
None (Tentative Approval) |