Application 085979
- Type
- ANDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRAMOSONE | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | LOTION;TOPICAL | 2.5%;1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-726 | Pramosone | hydrocortisone acetate and pramoxine hydrochloride | Sebela Pharmaceuticals Inc. | ANDA | Current |
| 54766-829 | Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | Sebela Pharmaceuticals Inc. | ANDA | Current |