Skip to contentApplication 208901
- Type
- NDA
- Sponsor
- MAYNE PHARMA INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOLSURA | ITRACONAZOLE | CAPSULE;ORAL | 65MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51862-462 | Tolsura | Itraconazole | Mayne Pharma Inc. | NDA | Current |
| 51862-462 | Tolsura | Itraconazole | Mayne Pharma Inc. | NDA | Current |
| 51862-462 | Tolsura | Itraconazole | Mayne Pharma Inc. | NDA | Current |
| 51862-462 | Tolsura | Itraconazole | Mayne Pharma Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80032 | SUPPL | 2024-10-29 |
| 80023 | SUPPL | 2024-10-28 |
| 58804 | ORIG | 2019-05-21 |
| 56838 | ORIG | 2018-12-20 |
| 56716 | ORIG | 2018-12-12 |