| NAFAZAIR |
040073 |
001 |
ANDA |
NAPHAZOLINE HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
0.1% |
No
|
No
|
1994/05/25
|
1994/05/25
|
BAUSCH AND LOMB |
Discontinued |
| OTICAIR |
064065 |
001 |
ANDA |
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
SUSPENSION/DROPS;OTIC |
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
No
|
No
|
1996/08/28
|
1996/08/28
|
BAUSCH AND LOMB |
Prescription |
| SINGULAIR |
020829 |
002 |
NDA |
MONTELUKAST SODIUM |
TABLET;ORAL |
EQ 10MG BASE |
Yes
|
Yes
|
1998/02/20
|
1998/02/20
|
ORGANON |
Prescription |
| SINGULAIR |
020830 |
001 |
NDA |
MONTELUKAST SODIUM |
TABLET, CHEWABLE;ORAL |
EQ 5MG BASE |
Yes
|
Yes
|
1998/02/20
|
1998/02/20
|
ORGANON |
Prescription |
| SINGULAIR |
020830 |
002 |
NDA |
MONTELUKAST SODIUM |
TABLET, CHEWABLE;ORAL |
EQ 4MG BASE |
Yes
|
No
|
1998/02/20
|
2000/03/03
|
ORGANON |
Prescription |
| ADVAIR DISKUS 100/50 |
021077 |
001 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.1MG/INH;EQ 0.05MG BASE/INH |
Yes
|
Yes
|
2000/08/24
|
2000/08/24
|
GLAXO GRP LTD |
Prescription |
| ADVAIR DISKUS 250/50 |
021077 |
002 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.25MG/INH;EQ 0.05MG BASE/INH |
Yes
|
Yes
|
2000/08/24
|
2000/08/24
|
GLAXO GRP LTD |
Prescription |
| ADVAIR DISKUS 500/50 |
021077 |
003 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.5MG/INH;EQ 0.05MG BASE/INH |
Yes
|
Yes
|
2000/08/24
|
2000/08/24
|
GLAXO GRP LTD |
Prescription |
| SINGULAIR |
021409 |
001 |
NDA |
MONTELUKAST SODIUM |
GRANULE;ORAL |
EQ 4MG BASE/PACKET |
Yes
|
Yes
|
2002/07/26
|
2002/07/26
|
ORGANON |
Prescription |
| XOLAIR |
103976 |
001 |
BLA |
OMALIZUMAB |
VIAL |
150MG/VIAL |
No
|
No
|
2003/06/20
|
--
|
GENENTECH |
Prescription |
| XOLAIR |
103976 |
002 |
BLA |
OMALIZUMAB |
SYRINGE |
75MG/0.5ML |
No
|
No
|
2003/06/20
|
--
|
GENENTECH |
Prescription |
| XOLAIR |
103976 |
003 |
BLA |
OMALIZUMAB |
SYRINGE |
150MG/ML |
No
|
No
|
2003/06/20
|
--
|
GENENTECH |
Prescription |
| XOLAIR |
103976 |
004 |
BLA |
OMALIZUMAB |
SYRINGE |
300MG/2ML |
No
|
No
|
2003/06/20
|
--
|
GENENTECH |
Prescription |
| PROAIR HFA |
021457 |
001 |
NDA |
ALBUTEROL SULFATE |
AEROSOL, METERED;INHALATION |
EQ 0.09MG BASE/INH |
Yes
|
Yes
|
2004/10/29
|
2004/10/29
|
TEVA BRANDED PHARM |
Prescription |
| ADVAIR HFA |
021254 |
001 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
AEROSOL, METERED;INHALATION |
0.045MG/INH;EQ 0.021MG BASE/INH |
Yes
|
Yes
|
2006/06/08
|
2006/06/08
|
GLAXO GRP LTD |
Prescription |
| ADVAIR HFA |
021254 |
002 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
AEROSOL, METERED;INHALATION |
0.115MG/INH;EQ 0.021MG BASE/INH |
Yes
|
Yes
|
2006/06/08
|
2006/06/08
|
GLAXO GRP LTD |
Prescription |
| ADVAIR HFA |
021254 |
003 |
NDA |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
AEROSOL, METERED;INHALATION |
0.23MG/INH;EQ 0.021MG BASE/INH |
Yes
|
Yes
|
2006/06/08
|
2006/06/08
|
GLAXO GRP LTD |
Prescription |
| LETAIRIS |
022081 |
001 |
NDA |
AMBRISENTAN |
TABLET;ORAL |
5MG |
Yes
|
No
|
2007/06/15
|
2007/06/15
|
GILEAD |
Prescription |
| LETAIRIS |
022081 |
002 |
NDA |
AMBRISENTAN |
TABLET;ORAL |
10MG |
Yes
|
Yes
|
2007/06/15
|
2007/06/15
|
GILEAD |
Prescription |
| TUDORZA PRESSAIR |
202450 |
001 |
NDA |
ACLIDINIUM BROMIDE |
POWDER, METERED;INHALATION |
0.4MG/INH |
Yes
|
Yes
|
2012/07/23
|
2012/07/23
|
COVIS |
Prescription |