JORNAY PM |
209311 |
001 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
20MG |
Yes
|
No
|
2018/08/08
|
2018/08/08
|
IRONSHORE PHARMS |
Prescription |
JORNAY PM |
209311 |
002 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Yes
|
No
|
2018/08/08
|
2018/08/08
|
IRONSHORE PHARMS |
Prescription |
JORNAY PM |
209311 |
003 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Yes
|
No
|
2018/08/08
|
2018/08/08
|
IRONSHORE PHARMS |
Prescription |
JORNAY PM |
209311 |
004 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Yes
|
No
|
2018/08/08
|
2018/08/08
|
IRONSHORE PHARMS |
Prescription |
JORNAY PM |
209311 |
005 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
Yes
|
Yes
|
2018/08/08
|
2018/08/08
|
IRONSHORE PHARMS |
Prescription |