ANVISA-2020-0085
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-085
Application Number
ANVISA-2020-0085
Procedure Type
sNDA
Status
Failed
Linked Product
Market Authorization
Poland · ANVISA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-085 | eCTD | 5.6.9 | 5 | M1 (14), M2 (13), M3 (9), M4 (9), M5 (4) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-01-20 | high | Open |
| Information request: extractables and leachables data | 2025-04-20 | low | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-07-08 | medium | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2024-11-08 | medium | Open |
| Update SmPC section 4.4 with hepatic impairment data | 2025-09-25 | medium | Blocked |
| Validate analytical method for dissolution test per USP <711> | 2025-05-10 | medium | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANVISA-2020-0085-V085 | Type II | Draft | 2024-02-05 |
| ANVISA-2020-0085-V185 | Type II | Blocked | 2023-10-15 |
| ANVISA-2020-0085-V285 | Type IA | Submitted | 2023-02-23 |
| ANVISA-2020-0085-V385 | Minor | Failed | 2022-09-11 |
| ANVISA-2020-0085-V485 | Type II | Completed | 2024-04-25 |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.