NUCYNTA |
022304 |
001 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET;ORAL |
EQ 50MG BASE |
Yes
|
No
|
2008/11/20
|
2008/11/20
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA |
022304 |
002 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET;ORAL |
EQ 75MG BASE |
Yes
|
No
|
2008/11/20
|
2008/11/20
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA |
022304 |
003 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET;ORAL |
EQ 100MG BASE |
Yes
|
Yes
|
2008/11/20
|
2008/11/20
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA ER |
200533 |
001 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG BASE |
Yes
|
No
|
2011/08/25
|
2011/08/25
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA ER |
200533 |
002 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 100MG BASE |
Yes
|
No
|
2011/08/25
|
2011/08/25
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA ER |
200533 |
003 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 150MG BASE |
Yes
|
No
|
2011/08/25
|
2011/08/25
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA ER |
200533 |
004 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 200MG BASE |
Yes
|
No
|
2011/08/25
|
2011/08/25
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA ER |
200533 |
005 |
NDA |
TAPENTADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 250MG BASE |
Yes
|
Yes
|
2011/08/25
|
2011/08/25
|
COLLEGIUM PHARM INC |
Prescription |
NUCYNTA |
203794 |
001 |
NDA |
TAPENTADOL HYDROCHLORIDE |
SOLUTION;ORAL |
EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2012/10/15
|
2012/10/15
|
COLLEGIUM PHARM INC |
Discontinued |