Application 204268
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
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 |
|---|---|---|---|---|---|
| 16714-967 | testosterone | testosterone | Northstar Rx LLC | ANDA | Current |
| 16714-967 | testosterone | testosterone | Northstar RxLLC | ANDA | Current |
| 16714-967 | testosterone | testosterone | Northstar RxLLC | ANDA | Current |
| 16714-967 | testosterone | testosterone | Northstar RxLLC | ANDA | Current |
| 45802-754 | testosterone | testosterone | Perrigo New York Inc | ANDA | Current |
| 45802-754 | testosterone | testosterone | Perrigo New York Inc | ANDA | Current |
| 45802-754 | testosterone | testosterone | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-754 | testosterone | testosterone | Perrigo New York Inc | ANDA | Current |
| 45802-754 | testosterone | testosterone | Perrigo New York Inc | ANDA | Current |
| 63629-8455 | testosterone | testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8455 | testosterone | testosterone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8455 | testosterone | testosterone | Bryant Ranch Prepack | ANDA | Current |