RELEXXII |
216117 |
001 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
18MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
002 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
27MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
003 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
36MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
004 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
45MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
005 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
54MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
006 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
63MG |
Yes
|
No
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |
RELEXXII |
216117 |
007 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
72MG |
Yes
|
Yes
|
2022/06/23
|
2022/06/23
|
OSMOTICA PHARM US |
Prescription |