| LEVETIRACETAM |
091291 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
CHARTWELL RX |
Discontinued |
| LEVETIRACETAM |
091399 |
001 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
LUPIN LTD |
Prescription |
| LEVETIRACETAM |
091399 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
LUPIN LTD |
Prescription |
| LEVETIRACETAM |
091430 |
001 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
TEVA PHARMS |
Discontinued |
| LEVETIRACETAM |
091430 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
TEVA PHARMS |
Discontinued |
| LEVETIRACETAM |
091557 |
001 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
ACTAVIS ELIZABETH |
Discontinued |
| LEVETIRACETAM |
091557 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/09/12
|
2011/09/12
|
ACTAVIS ELIZABETH |
Discontinued |
| LEVETIRACETAM |
091360 |
001 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2011/10/04
|
2011/10/04
|
ENDO OPERATIONS |
Discontinued |
| LEVETIRACETAM |
091360 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/10/04
|
2011/10/04
|
ENDO OPERATIONS |
Discontinued |
| LEVETIRACETAM |
090981 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
No
|
No
|
2011/10/13
|
2011/10/13
|
HIKMA FARMACEUTICA |
Prescription |
| LEVETIRACETAM |
090893 |
001 |
ANDA |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
No
|
No
|
2011/10/17
|
2011/10/17
|
LUPIN LTD |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
001 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/100ML (5MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
002 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
003 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
1.5GM/100ML (15MG/ML) |
Yes
|
Yes
|
2011/11/09
|
2011/11/09
|
HQ SPCLT PHARMA |
Prescription |
| LEVETIRACETAM IN SODIUM CHLORIDE |
202543 |
004 |
NDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/11/09
|
2020/12/14
|
HQ SPCLT PHARMA |
Discontinued |
| LEVETIRACETAM |
200475 |
001 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
No
|
No
|
2011/12/19
|
2011/12/19
|
AUROBINDO PHARMA USA |
Discontinued |
| LEVETIRACETAM |
200475 |
002 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
No
|
No
|
2011/12/19
|
2011/12/19
|
AUROBINDO PHARMA USA |
Discontinued |
| LEVETIRACETAM |
200475 |
003 |
ANDA |
LEVETIRACETAM |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
No
|
No
|
2011/12/19
|
2015/12/07
|
AUROBINDO PHARMA USA |
Discontinued |
| LEVETIRACETAM |
202143 |
001 |
ANDA |
LEVETIRACETAM |
INJECTABLE;INTRAVENOUS |
500MG/5ML (100MG/ML) |
No
|
No
|
2012/01/31
|
2012/01/31
|
AM REGENT |
Discontinued |
| LEVETIRACETAM |
090601 |
001 |
ANDA |
LEVETIRACETAM |
SOLUTION;ORAL |
100MG/ML |
No
|
No
|
2012/02/28
|
2012/02/28
|
HIKMA |
Discontinued |