Application 017351
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORTIFOAM | HYDROCORTISONE ACETATE | AEROSOL, METERED;RECTAL | 10% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-6830 | Cortifoam | hydrocortisone acetate | Meda Pharmaceuticals | NDA | Current |
| 0037-6830 | Cortifoam | hydrocortisone acetate | Meda Pharmaceuticals | NDA | Current |
| 0037-6830 | Cortifoam | hydrocortisone acetate | Meda Pharmaceuticals | NDA | Current |
| 0037-6830 | Cortifoam | hydrocortisone acetate | Meda Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77701 | SUPPL | 2024-03-04 |
| 77695 | SUPPL | 2024-03-04 |
| 20072 | SUPPL | 2006-05-08 |
| 20071 | SUPPL | 2005-03-08 |
| 13108 | SUPPL | 2003-12-11 |
| 563 | SUPPL | 2002-07-08 |