Skip to contentApplication 219531
- Type
- NDA
- Sponsor
- BRILLIAN PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SDAMLO | AMLODIPINE BESYLATE | FOR SOLUTION;ORAL | EQ 2.5MG BASE/BOT | Yes | Yes |
| 002 | SDAMLO | AMLODIPINE BESYLATE | FOR SOLUTION;ORAL | EQ 5MG BASE/BOT | Yes | Yes |
| 003 | SDAMLO | AMLODIPINE BESYLATE | FOR SOLUTION;ORAL | EQ 10MG BASE/BOT | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85871 | SUPPL | 2026-05-11 |
| 83798 | ORIG | 2025-10-17 |
| 82960 | ORIG | 2025-07-28 |
| 82942 | ORIG | 2025-07-25 |