HSA-2023-0052
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-052
Application Number
HSA-2023-0052
Procedure Type
Type IA Variation
Status
Active
Linked Product
Market Authorization
Saudi Arabia · HSA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-052 | CTD | 1.4.6 | 5 | M1 (8), M2 (4), M3 (6), M4 (14), M5 (6) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for benefit-risk assessment addendum | 2025-01-05 | medium | Open |
| Question on comparative dissolution data | 2025-04-03 | medium | Open |
| Information request: manufacturing process change justification | 2025-01-17 | medium | Overdue |
| Request for post-marketing commitment progress update | 2025-03-03 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-06-21 | low | Overdue |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-11-03 | high | In Progress |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-12-14 | medium | Overdue |
| Provide carcinogenicity study report for 2-year rat study | 2025-05-29 | medium | Blocked |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-154 | IFU | 7.9 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HSA-2023-0052-V052 | Type IB | Failed | pending |
| HSA-2023-0052-V152 | Major | Failed | pending |
| HSA-2023-0052-V252 | Type II | Completed | pending |
| HSA-2023-0052-V352 | Type IA | Active | 2024-06-13 |
| HSA-2023-0052-V452 | Type II | In Progress | 2023-06-03 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 2, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.