Application 210835
- Type
- ANDA
- Sponsor
- XIROMED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-2352 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2352 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2352 | Testosterone | Testosterone | Bryant Ranch Prepack | ANDA | Current |
| 70700-112 | Testosterone | Testosterone | Xiromed, LLC | ANDA | Current |
| 70700-112 | Testosterone | Testosterone | Xiromed, LLC | ANDA | Current |