CDSCO-2022-0013
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-013
Application Number
CDSCO-2022-0013
Procedure Type
NDA
Status
In Progress
Linked Product
Market Authorization
Spain · CDSCO
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-013 | eCTD | 6.0.6 | 5 | M1 (7), M2 (4), M3 (6), M4 (10), M5 (12) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-02-08 | low | In Progress |
| Request for updated SmPC section 4.1 | 2025-04-22 | medium | Open |
| Information request: manufacturing process change justification | 2025-02-11 | medium | Draft |
| GMP inspection findings clarification | 2024-12-05 | medium | In Progress |
| Question on comparative dissolution data | 2025-04-11 | high | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2024-12-30 | high | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-05-07 | low | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2024-11-30 | high | Open |
| Provide carcinogenicity study report for 2-year rat study | 2025-09-19 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-037 | IFU | 7.8 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| CDSCO-2022-0013-V013 | Type II | Overdue | pending |
| CDSCO-2022-0013-V113 | Type IA | Active | pending |
| CDSCO-2022-0013-V213 | Type II | Pending | 2022-09-30 |
| CDSCO-2022-0013-V313 | Minor | In Progress | 2023-06-26 |
| CDSCO-2022-0013-V413 | Type IA | Overdue | 2023-08-02 |
Inspection Readiness Risk Panel
Risk Score: 9 · Overdue commitments: 3, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.