| MEMANTINE HYDROCHLORIDE |
214651 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
No
|
2021/08/09
|
2021/08/09
|
AUROBINDO PHARMA LTD |
Prescription |
| MEMANTINE HYDROCHLORIDE |
214731 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
No
|
No
|
2022/08/11
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| MEMANTINE HYDROCHLORIDE |
214731 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
No
|
No
|
2022/08/11
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| MEMANTINE HYDROCHLORIDE |
214731 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
No
|
No
|
2022/08/11
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| MEMANTINE HYDROCHLORIDE |
214731 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
No
|
2022/08/11
(TA)
|
--
|
NOVAST LABS LTD |
None (Tentative Approval) |
| MEMANTINE HYDROCHLORIDE |
204389 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2022/09/26
|
2022/09/26
|
HETERO LABS LTD V |
Prescription |
| MEMANTINE HYDROCHLORIDE |
204389 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2022/09/26
|
2022/09/26
|
HETERO LABS LTD V |
Prescription |
| MEMANTINE HYDROCHLORIDE |
213985 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
No
|
No
|
2022/10/11
|
2022/10/11
|
XIAMEN LP PHARM CO |
Prescription |
| MEMANTINE HYDROCHLORIDE |
213985 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
No
|
No
|
2022/10/11
|
2022/10/11
|
XIAMEN LP PHARM CO |
Prescription |
| MEMANTINE HYDROCHLORIDE |
213985 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
No
|
2022/10/11
|
2022/10/11
|
XIAMEN LP PHARM CO |
Prescription |
| MEMANTINE HYDROCHLORIDE |
213985 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
No
|
No
|
2022/10/11
|
2024/02/06
|
XIAMEN LP PHARM CO |
Prescription |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
208237 |
001 |
ANDA |
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG;21MG |
No
|
No
|
2023/12/15
|
2023/12/15
|
ANI PHARMS |
Prescription |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
208237 |
001 |
ANDA |
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG;21MG |
No
|
No
|
2023/12/15
(TA)
|
2023/12/15
|
ANI PHARMS |
Prescription |