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Application 218276
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FABHALTA | IPTACOPAN HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81681 | SUPPL | 2025-03-24 |
| 81662 | SUPPL | 2025-03-20 |
| 81661 | SUPPL | 2025-03-20 |
| 79352 | SUPPL | 2024-08-09 |
| 79326 | SUPPL | 2024-08-07 |
| 78565 | SUPPL | 2024-05-28 |
| 77999 | SUPPL | 2024-03-27 |
| 77981 | SUPPL | 2024-03-27 |
| 77151 | ORIG | 2023-12-27 |
| 76744 | ORIG | 2023-12-06 |
| 76739 | ORIG | 2023-12-06 |