CLARITIN |
019658 |
002 |
NDA |
LORATADINE |
TABLET;ORAL |
10MG |
Yes
|
Yes
|
1993/04/12
|
2002/11/27
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN HIVES RELIEF |
019658 |
003 |
NDA |
LORATADINE |
TABLET;ORAL |
10MG |
Yes
|
Yes
|
1993/04/12
|
2003/11/19
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN-D |
019670 |
002 |
NDA |
LORATADINE; PSEUDOEPHEDRINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;120MG |
Yes
|
Yes
|
1994/11/14
|
2002/11/27
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN-D 24 HOUR |
020470 |
002 |
NDA |
LORATADINE; PSEUDOEPHEDRINE SULFATE |
TABLET, EXTENDED RELEASE;ORAL |
10MG;240MG |
Yes
|
Yes
|
1996/08/23
|
2002/11/27
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN |
020641 |
002 |
NDA |
LORATADINE |
SYRUP;ORAL |
1MG/ML |
Yes
|
Yes
|
1996/10/10
|
2002/11/27
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN HIVES RELIEF |
020641 |
003 |
NDA |
LORATADINE |
SYRUP;ORAL |
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1996/10/10
|
2003/11/19
|
BAYER HEALTHCARE LLC |
Discontinued |
CLARITIN REDITABS |
020704 |
002 |
NDA |
LORATADINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
10MG |
Yes
|
Yes
|
1996/12/23
|
2002/11/27
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN HIVES RELIEF REDITAB |
020704 |
003 |
NDA |
LORATADINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
10MG |
Yes
|
Yes
|
1996/12/23
|
2003/11/19
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CHILDREN'S CLARITIN |
021891 |
001 |
NDA |
LORATADINE |
TABLET, CHEWABLE;ORAL |
5MG |
Yes
|
No
|
2006/08/23
|
2006/08/23
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN |
021891 |
002 |
NDA |
LORATADINE |
TABLET, CHEWABLE;ORAL |
10MG |
Yes
|
Yes
|
2006/08/23
|
2018/11/21
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN REDITABS |
021993 |
001 |
NDA |
LORATADINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
5MG |
Yes
|
Yes
|
2006/12/12
|
2006/12/12
|
BAYER HEALTHCARE LLC |
Over-the-counter |
CLARITIN |
021952 |
001 |
NDA |
LORATADINE |
CAPSULE;ORAL |
10MG |
Yes
|
Yes
|
2008/06/16
|
2008/06/16
|
BAYER HEALTHCARE LLC |
Over-the-counter |