FOCALIN |
021278 |
001 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
2.5MG |
Yes
|
No
|
2001/11/13
|
2001/11/13
|
SANDOZ |
Prescription |
FOCALIN |
021278 |
002 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Yes
|
No
|
2001/11/13
|
2001/11/13
|
SANDOZ |
Prescription |
FOCALIN |
021278 |
003 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Yes
|
Yes
|
2001/11/13
|
2001/11/13
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
001 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
5MG |
Yes
|
No
|
2005/05/26
|
2005/05/26
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
002 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
10MG |
Yes
|
No
|
2005/05/26
|
2005/05/26
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
003 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
20MG |
Yes
|
No
|
2005/05/26
|
2005/05/26
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
004 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Yes
|
No
|
2005/05/26
|
2006/08/01
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
005 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Yes
|
No
|
2005/05/26
|
2009/10/23
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
006 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Yes
|
Yes
|
2005/05/26
|
2010/08/11
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
007 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Yes
|
No
|
2005/05/26
|
2011/04/21
|
SANDOZ |
Prescription |
FOCALIN XR |
021802 |
008 |
NDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Yes
|
No
|
2005/05/26
|
2011/04/21
|
SANDOZ |
Prescription |