HC-2024-0006
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-006
Application Number
HC-2024-0006
Procedure Type
sNDA
Status
Active
Linked Product
Market Authorization
Canada · HC
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-006 | eCTD | 8.0.6 | 5 | M1 (4), M2 (11), M3 (6), M4 (14), M5 (15) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency: inadequate paediatric data justification | 2025-03-30 | low | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2025-01-27 | high | Draft |
| Information request: manufacturing process change justification | 2025-01-25 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-07-24 | low | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-03-20 | medium | Open |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-08-27 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-016 | Labeling | 9.6 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HC-2024-0006-V006 | Major | Approved | pending |
| HC-2024-0006-V106 | Type IA | Submitted | 2023-11-20 |
| HC-2024-0006-V206 | Type IB | Overdue | pending |
| HC-2024-0006-V306 | Type II | Overdue | pending |
| HC-2024-0006-V406 | Type IA | Active | pending |
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.