| METHYLIN ER |
075629 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
No
|
No
|
2000/05/09
|
2000/05/09
|
SPECGX LLC |
Prescription |
| METHYLIN ER |
075629 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
20MG |
No
|
No
|
2000/05/09
|
2000/05/09
|
SPECGX LLC |
Prescription |
| METHYLIN |
021419 |
001 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Yes
|
Yes
|
2002/12/19
|
2002/12/19
|
SPECGX LLC |
Prescription |
| METHYLIN |
021419 |
002 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
SOLUTION;ORAL |
10MG/5ML |
Yes
|
Yes
|
2002/12/19
|
2002/12/19
|
SPECGX LLC |
Prescription |
| METHYLIN |
021475 |
001 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, CHEWABLE;ORAL |
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2003/04/15
|
2003/04/15
|
SPECGX LLC |
Discontinued |
| METHYLIN |
021475 |
002 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, CHEWABLE;ORAL |
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2003/04/15
|
2003/04/15
|
SPECGX LLC |
Discontinued |
| METHYLIN |
021475 |
003 |
NDA |
METHYLPHENIDATE HYDROCHLORIDE |
TABLET, CHEWABLE;ORAL |
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2003/04/15
|
2003/04/15
|
SPECGX LLC |
Discontinued |