SFDA-2023-0097
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-097
Application Number
SFDA-2023-0097
Procedure Type
sNDA
Status
Completed
Linked Product
Market Authorization
Australia · SFDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-097 | CTD | 4.2.8 | 5 | M1 (9), M2 (7), M3 (9), M4 (7), M5 (3) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| GMP inspection findings clarification | 2025-01-13 | medium | Open |
| Question on comparative dissolution data | 2025-02-25 | low | In Progress |
| Query: container closure integrity study methodology | 2025-02-25 | high | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit harmonised global label per ICH Q12 PLCR | 2026-01-10 | low | In Progress |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-10-24 | low | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-01-22 | high | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-289 | IFU | 2.3 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SFDA-2023-0097-V097 | Minor | Failed | 2024-06-04 |
| SFDA-2023-0097-V197 | Type II | Approved | 2023-01-13 |
| SFDA-2023-0097-V297 | Type II | Failed | 2023-11-25 |
| SFDA-2023-0097-V397 | Type II | Draft | 2024-01-26 |
| SFDA-2023-0097-V497 | Type IB | Overdue | 2024-04-09 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.