| MEMANTINE HYDROCHLORIDE |
206135 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
No
|
No
|
2016/11/22
|
2016/11/22
|
APOTEX |
Prescription |
| MEMANTINE HYDROCHLORIDE |
206135 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
No
|
2016/11/22
|
2016/11/22
|
APOTEX |
Prescription |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
208328 |
001 |
ANDA |
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG;14MG |
No
|
No
|
2017/01/27
|
2017/01/27
|
AMNEAL PHARMS |
Discontinued |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
208328 |
002 |
ANDA |
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG;28MG |
No
|
No
|
2017/01/27
|
2017/01/27
|
AMNEAL PHARMS |
Discontinued |
| MEMANTINE HYDROCHLORIDE |
202350 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2017/05/23
|
2017/05/23
|
STRIDES PHARMA |
Prescription |
| MEMANTINE HYDROCHLORIDE |
202350 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2017/05/23
|
2017/05/23
|
STRIDES PHARMA |
Prescription |
| MEMANTINE HYDROCHLORIDE |
205784 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
No
|
No
|
2017/06/09
|
2017/06/09
|
ENDO OPERATIONS |
Discontinued |
| MEMANTINE HYDROCHLORIDE |
205784 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
No
|
No
|
2017/06/09
|
2017/06/09
|
ENDO OPERATIONS |
Discontinued |
| MEMANTINE HYDROCHLORIDE |
205784 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
No
|
No
|
2017/06/09
|
2017/06/09
|
ENDO OPERATIONS |
Discontinued |
| MEMANTINE HYDROCHLORIDE |
205784 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
No
|
2017/06/09
|
2017/06/09
|
ENDO OPERATIONS |
Discontinued |
| MEMANTINE HYDROCHLORIDE |
090961 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2017/07/10
|
2017/07/10
|
ZYDUS LIFESCIENCES |
Prescription |
| MEMANTINE HYDROCHLORIDE |
090961 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2017/07/10
|
2017/07/10
|
ZYDUS LIFESCIENCES |
Prescription |
| MEMANTINE HYDROCHLORIDE |
203293 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
No
|
No
|
2017/08/03
|
2017/08/03
|
ZYDUS PHARMS |
Prescription |
| MEMANTINE HYDROCHLORIDE |
203293 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
No
|
No
|
2017/08/03
|
2017/08/03
|
ZYDUS PHARMS |
Prescription |
| MEMANTINE HYDROCHLORIDE |
203293 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
No
|
No
|
2017/08/03
|
2017/08/03
|
ZYDUS PHARMS |
Prescription |
| MEMANTINE HYDROCHLORIDE |
203293 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
No
|
Yes
|
2017/08/03
|
2017/08/03
|
ZYDUS PHARMS |
Prescription |
| DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE |
208672 |
002 |
ANDA |
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG;28MG |
No
|
No
|
2017/10/10
(TA)
|
--
|
MACLEODS PHARMS LTD |
None (Tentative Approval) |
| MEMANTINE HYDROCHLORIDE |
209955 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
SOLUTION;ORAL |
2MG/ML |
No
|
No
|
2018/02/09
|
2018/02/09
|
APOTEX |
Prescription |
| MEMANTINE HYDROCHLORIDE |
209527 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
No
|
No
|
2018/05/07
|
2018/05/07
|
ACME LABS |
Prescription |
| MEMANTINE HYDROCHLORIDE |
209527 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
No
|
No
|
2018/05/07
|
2018/05/07
|
ACME LABS |
Prescription |