ANDROGEL |
021015 |
001 |
NDA |
TESTOSTERONE |
GEL;TRANSDERMAL |
25MG/2.5GM PACKET |
Yes
|
No
|
2000/02/28
|
2000/02/28
|
BESINS HLTHCARE |
Prescription |
ANDROGEL |
021015 |
002 |
NDA |
TESTOSTERONE |
GEL;TRANSDERMAL |
50MG/5GM PACKET |
Yes
|
No
|
2000/02/28
|
2000/02/28
|
BESINS HLTHCARE |
Prescription |
ANDROGEL |
021015 |
003 |
NDA |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
12.5MG/1.25GM ACTUATION |
Yes
|
No
|
2000/02/28
|
2003/09/26
|
BESINS HLTHCARE |
Prescription |
ANDROGEL |
022309 |
001 |
NDA |
TESTOSTERONE |
GEL, METERED;TRANSDERMAL |
1.62% (20.25MG/1.25GM ACTUATION) |
Yes
|
Yes
|
2011/04/29
|
2011/04/29
|
BESINS HLTHCARE |
Prescription |
ANDROGEL |
022309 |
002 |
NDA |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
2011/04/29
|
2012/09/07
|
BESINS HLTHCARE |
Discontinued |
ANDROGEL |
022309 |
003 |
NDA |
TESTOSTERONE |
GEL;TRANSDERMAL |
1.62% (40.5MG/2.5GM PACKET) |
Yes
|
No
|
2011/04/29
|
2012/09/07
|
BESINS HLTHCARE |
Prescription |