Skip to contentApplication 212862
- Type
- NDA
- Sponsor
- MYLAN IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRETOMANID | PRETOMANID | TABLET;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty L.P. | NDA | Current |
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty L.P. | NDA | Current |
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty L.P. | NDA | Current |
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty L.P. | NDA | Current |
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty LP | NDA | Current |
| 49502-476 | Pretomanid | Pretomanid | Mylan Specialty L.P. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80424 | SUPPL | 2024-11-26 |
| 80355 | SUPPL | 2024-11-25 |
| 80354 | SUPPL | 2024-11-25 |
| 73007 | SUPPL | 2022-12-22 |
| 73006 | SUPPL | 2022-12-22 |
| 73000 | SUPPL | 2022-12-22 |
| 59986 | ORIG | 2019-09-12 |
| 59738 | ORIG | 2019-08-16 |
| 59702 | ORIG | 2019-08-14 |
| 59701 | ORIG | 2019-08-14 |