Application 040396
- Type
- ANDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MICORT-HC | HYDROCORTISONE ACETATE | CREAM;TOPICAL | 2.5% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-835 | MiCort HC | hydrocortisone acetate | Sebela Pharmaceuticals Inc. | ANDA | Current |
| 54766-835 | MiCort HC | hydrocortisone acetate | Sebela Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 29948 | ORIG | 2001-02-27 |