| FENTANYL CITRATE |
079075 |
001 |
ANDA |
FENTANYL CITRATE |
TABLET;BUCCAL, SUBLINGUAL |
EQ 0.1MG BASE |
No
|
No
|
2011/01/07
|
2011/01/07
|
WATSON LABS |
Discontinued |
| FENTANYL CITRATE |
079075 |
002 |
ANDA |
FENTANYL CITRATE |
TABLET;BUCCAL, SUBLINGUAL |
EQ 0.2MG BASE |
No
|
No
|
2011/01/07
|
2011/01/07
|
WATSON LABS |
Discontinued |
| FENTANYL CITRATE |
079075 |
003 |
ANDA |
FENTANYL CITRATE |
TABLET;BUCCAL, SUBLINGUAL |
EQ 0.4MG BASE |
No
|
No
|
2011/01/07
|
2011/01/07
|
WATSON LABS |
Discontinued |
| FENTANYL CITRATE |
079075 |
004 |
ANDA |
FENTANYL CITRATE |
TABLET;BUCCAL, SUBLINGUAL |
EQ 0.6MG BASE |
No
|
No
|
2011/01/07
|
2011/01/07
|
WATSON LABS |
Discontinued |
| FENTANYL CITRATE |
079075 |
005 |
ANDA |
FENTANYL CITRATE |
TABLET;BUCCAL, SUBLINGUAL |
EQ 0.8MG BASE |
No
|
No
|
2011/01/07
|
2011/01/07
|
WATSON LABS |
Discontinued |
| FENTANYL-25 |
077154 |
001 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
No
|
Yes
|
2011/02/09
|
2011/02/09
|
SPECGX LLC |
Prescription |
| FENTANYL-50 |
077154 |
002 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
50MCG/HR |
No
|
No
|
2011/02/09
|
2011/02/09
|
SPECGX LLC |
Prescription |
| FENTANYL-75 |
077154 |
003 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
75MCG/HR |
No
|
No
|
2011/02/09
|
2011/02/09
|
SPECGX LLC |
Prescription |
| FENTANYL-100 |
077154 |
004 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
100MCG/HR |
No
|
No
|
2011/02/09
|
2011/02/09
|
SPECGX LLC |
Prescription |
| FENTANYL-12 |
077154 |
005 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
No
|
No
|
2011/02/09
|
2015/06/11
|
SPECGX LLC |
Prescription |
| FENTANYL-37 |
077154 |
006 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
37.5MCG/HR |
No
|
No
|
2011/02/09
|
2020/01/14
|
SPECGX LLC |
Prescription |
| FENTANYL-62 |
077154 |
007 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
62.5MCG/HR |
No
|
No
|
2011/02/09
|
2020/01/14
|
SPECGX LLC |
Prescription |
| FENTANYL |
202577 |
001 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
100MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL |
202577 |
002 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
200MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL |
202577 |
003 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
300MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL |
202577 |
004 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
400MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL |
202577 |
005 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
600MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL |
202577 |
006 |
ANDA |
FENTANYL |
TABLET;BUCCAL |
800MCG |
No
|
No
|
2015/03/04
(TA)
|
--
|
MYLAN PHARMS INC |
None (Tentative Approval) |
| FENTANYL-12 |
202097 |
001 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
12.5MCG/HR |
No
|
No
|
2016/11/04
|
2016/11/04
|
KINDEVA |
Prescription |
| FENTANYL-25 |
202097 |
002 |
ANDA |
FENTANYL |
FILM, EXTENDED RELEASE;TRANSDERMAL |
25MCG/HR |
No
|
No
|
2016/11/04
|
2016/11/04
|
KINDEVA |
Prescription |