Application 083778
- Type
- ANDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMOSONE | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | CREAM;TOPICAL | 0.5%;1% | No | No |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAMOSONE | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | CREAM;TOPICAL | 0.5%;1% | No | No |