MFDS-2020-0090
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-090
Application Number
MFDS-2020-0090
Procedure Type
NDA
Status
Overdue
Linked Product
Market Authorization
Denmark · MFDS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-090 | NeeS | 2.6.2 | 5 | M1 (15), M2 (6), M3 (9), M4 (4), M5 (8) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2024-12-31 | medium | Open |
| Request for post-marketing commitment progress update | 2024-12-20 | medium | Open |
| Request for additional clinical data on primary endpoint | 2025-02-17 | medium | Open |
| Query: container closure integrity study methodology | 2025-01-01 | medium | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-01-07 | high | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-10-18 | low | Blocked |
| Validate analytical method for dissolution test per USP <711> | 2025-01-04 | high | In Progress |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-08-09 | medium | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2025-10-04 | low | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-268 | SmPC | 1.9 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MFDS-2020-0090-V090 | Minor | Pending | 2023-08-20 |
| MFDS-2020-0090-V190 | Type IB | Failed | 2022-11-26 |
| MFDS-2020-0090-V290 | Minor | Overdue | pending |
| MFDS-2020-0090-V390 | Minor | In Progress | 2023-11-07 |
| MFDS-2020-0090-V490 | Type IA | In Progress | 2023-07-06 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.