FdaApplication
NDA 022309
Identifiers
- fda_app_no: NDA022309
Properties
| Property | Value |
|---|---|
| applicant_name | BESINS HEALTHCARE IRELAND LTD |
| application_type | NDA |
| approval_date | 2011-04-29 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL |
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL |
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL |
3 products