FdaApplication
NDA 021015
Identifiers
- fda_app_no: NDA021015
Properties
| Property | Value |
|---|---|
| applicant_name | BESINS HEALTHCARE IRELAND LTD |
| application_type | NDA |
| approval_date | 2000-02-28 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL |
| ANDROGEL | TESTOSTERONE | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED;TRANSDERMAL |
| ANDROGEL | TESTOSTERONE | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL |
3 products