FDA-2024-0041
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-041
Application Number
FDA-2024-0041
Procedure Type
sNDA
Status
Active
Linked Product
Market Authorization
France · FDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-041 | NeeS | 2.3.7 | 5 | M1 (3), M2 (11), M3 (9), M4 (5), M5 (3) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-01-11 | medium | Open |
| Request for updated SmPC section 4.1 | 2025-02-13 | high | In Progress |
| Deficiency letter: missing stability data for 40°C condition | 2025-03-23 | medium | Overdue |
| Request for post-marketing commitment progress update | 2025-01-07 | low | Draft |
| Information request: extractables and leachables data | 2024-12-17 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2024-12-28 | medium | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2024-11-16 | low | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-02-14 | low | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-04-19 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-121 | Labeling | 12.2 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| FDA-2024-0041-V041 | Type IB | Overdue | 2024-02-25 |
| FDA-2024-0041-V141 | Major | Completed | 2024-02-09 |
| FDA-2024-0041-V241 | Type IB | Failed | 2023-04-17 |
| FDA-2024-0041-V341 | Type II | Approved | 2024-01-07 |
| FDA-2024-0041-V441 | Major | Active | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.