ORAP |
017473 |
001 |
NDA |
PIMOZIDE |
TABLET;ORAL |
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1984/07/31
|
1984/07/31
|
TEVA |
Discontinued |
ORAP |
017473 |
003 |
NDA |
PIMOZIDE |
TABLET;ORAL |
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1984/07/31
|
1997/08/27
|
TEVA |
Discontinued |
CHLORAPREP ONE-STEP |
020832 |
001 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (3ML) |
Yes
|
Yes
|
2000/07/14
|
2000/07/14
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP WITH TINT |
020832 |
002 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (26ML) |
Yes
|
Yes
|
2000/07/14
|
2005/05/03
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP ONE-STEP FREPP |
020832 |
003 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (1.5ML) |
Yes
|
Yes
|
2000/07/14
|
2002/04/26
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP ONE-STEP |
020832 |
004 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (10.5ML) |
Yes
|
Yes
|
2000/07/14
|
2003/08/20
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP WITH TINT |
020832 |
005 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (10.5ML) |
Yes
|
Yes
|
2000/07/14
|
2006/04/03
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP ONE-STEP |
020832 |
006 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (26ML) |
Yes
|
Yes
|
2000/07/14
|
2006/11/21
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP WITH TINT |
020832 |
007 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (3ML) |
Yes
|
Yes
|
2000/07/14
|
2006/10/10
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP ONE-STEP |
020832 |
008 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SPONGE;TOPICAL |
2%;70% (1ML) |
Yes
|
Yes
|
2000/07/14
|
2008/10/23
|
BECTON DICKINSON CO |
Over-the-counter |
ORAPRED |
075117 |
001 |
ANDA |
PREDNISOLONE SODIUM PHOSPHATE |
SOLUTION;ORAL |
EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
2000/12/14
|
2000/12/14
|
CONCORDIA PHARMS INC |
Discontinued |
CHLORAPREP ONE-STEP SEPP |
021555 |
001 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SWAB;TOPICAL |
2%;70% (0.67ML) |
Yes
|
Yes
|
2002/10/07
|
2002/10/07
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP SINGLE SWABSTICK |
021555 |
002 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SWAB;TOPICAL |
2%;70% (1.75ML) |
Yes
|
Yes
|
2002/10/07
|
2005/05/10
|
BECTON DICKINSON CO |
Over-the-counter |
CHLORAPREP TRIPLE SWABSTICK |
021555 |
003 |
NDA |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
SWAB;TOPICAL |
2%;70% (5.25ML) |
Yes
|
Yes
|
2002/10/07
|
2009/06/10
|
BECTON DICKINSON CO |
Over-the-counter |
ORAPRED ODT |
021959 |
001 |
NDA |
PREDNISOLONE SODIUM PHOSPHATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Yes
|
No
|
2006/06/01
|
2006/06/01
|
CONCORDIA PHARMS INC |
Prescription |
ORAPRED ODT |
021959 |
002 |
NDA |
PREDNISOLONE SODIUM PHOSPHATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 15MG BASE |
Yes
|
No
|
2006/06/01
|
2006/06/01
|
CONCORDIA PHARMS INC |
Prescription |
ORAPRED ODT |
021959 |
003 |
NDA |
PREDNISOLONE SODIUM PHOSPHATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 30MG BASE |
Yes
|
Yes
|
2006/06/01
|
2006/06/01
|
CONCORDIA PHARMS INC |
Prescription |