Application 022484
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONMEL | ITRACONAZOLE | TABLET;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0259-1420 | Onmel | ITRACONAZOLE | Merz Pharmaceuticals, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24320 | ORIG | 2011-02-17 |
| 42535 | ORIG | 2011-01-11 |
| 38757 | ORIG | 2010-05-07 |
| 7455 | ORIG | 2010-05-05 |