KERLEDEX |
019807 |
001 |
NDA |
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE |
TABLET;ORAL |
5MG;12.5MG |
No
|
No
|
1992/10/30
|
1992/10/30
|
SANOFI AVENTIS US |
Discontinued |
KERLEDEX |
019807 |
002 |
NDA |
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE |
TABLET;ORAL |
10MG;12.5MG |
No
|
No
|
1992/10/30
|
1992/10/30
|
SANOFI AVENTIS US |
Discontinued |
EDEX |
020649 |
001 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.005MG/VIAL |
No
|
No
|
1997/06/12
|
1997/06/12
|
ENDO OPERATIONS |
Discontinued |
EDEX |
020649 |
002 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.01MG/VIAL |
Yes
|
No
|
1997/06/12
|
1997/06/12
|
ENDO OPERATIONS |
Prescription |
EDEX |
020649 |
003 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.02MG/VIAL |
Yes
|
No
|
1997/06/12
|
1997/06/12
|
ENDO OPERATIONS |
Prescription |
EDEX |
020649 |
004 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.04MG/VIAL |
Yes
|
Yes
|
1997/06/12
|
1997/06/12
|
ENDO OPERATIONS |
Prescription |
EDEX |
020649 |
005 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.01MG/VIAL |
Yes
|
Yes
|
1997/06/12
|
1998/07/30
|
ENDO OPERATIONS |
Prescription |
EDEX |
020649 |
006 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.02MG/VIAL |
Yes
|
Yes
|
1997/06/12
|
1998/07/30
|
ENDO OPERATIONS |
Prescription |
EDEX |
020649 |
007 |
NDA |
ALPROSTADIL |
INJECTABLE;INJECTION |
0.04MG/VIAL |
Yes
|
Yes
|
1997/06/12
|
1998/07/30
|
ENDO OPERATIONS |
Prescription |
PRECEDEX |
021038 |
001 |
NDA |
DEXMEDETOMIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) |
Yes
|
Yes
|
1999/12/17
|
1999/12/17
|
HOSPIRA |
Prescription |
PRECEDEX |
021038 |
002 |
NDA |
DEXMEDETOMIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) |
Yes
|
Yes
|
1999/12/17
|
2013/03/13
|
HOSPIRA |
Prescription |
PRECEDEX |
021038 |
003 |
NDA |
DEXMEDETOMIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) |
Yes
|
Yes
|
1999/12/17
|
2013/03/13
|
HOSPIRA |
Prescription |
PRECEDEX |
021038 |
004 |
NDA |
DEXMEDETOMIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) |
Yes
|
Yes
|
1999/12/17
|
2014/11/14
|
HOSPIRA |
Prescription |
PRECEDEX |
021038 |
005 |
NDA |
DEXMEDETOMIDINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) |
Yes
|
Yes
|
1999/12/17
|
2020/01/31
|
HOSPIRA |
Prescription |
NUEDEXTA |
021879 |
001 |
NDA |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
CAPSULE;ORAL |
20MG;10MG |
Yes
|
Yes
|
2010/10/29
|
2010/10/29
|
AVANIR PHARMS |
Prescription |