Application 219531
- Type
- NDA
- Sponsor
- BRILLIAN PHARMA
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N219531-001 | SDAMLO | AMLODIPINE BESYLATE | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | |
| N219531-002 | SDAMLO | AMLODIPINE BESYLATE | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | |
| N219531-003 | SDAMLO | AMLODIPINE BESYLATE | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N219531-001 | SDAMLO | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N219531-002 | SDAMLO | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N219531-003 | SDAMLO | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N219531-001 | SDAMLO | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N219531-002 | SDAMLO | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N219531-003 | SDAMLO | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N219531-001 | SDAMLO | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD | 2025-07-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N219531-002 | SDAMLO | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD | 2025-07-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N219531-003 | SDAMLO | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD | 2025-07-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N219531-001 | SDAMLO | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N219531-002 | SDAMLO | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N219531-003 | SDAMLO | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N219531-001 | SDAMLO | EQ 2.5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N219531-002 | SDAMLO | EQ 5MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N219531-003 | SDAMLO | EQ 10MG BASE/BOT | FOR SOLUTION / ORAL | RLD, RS | 2025-07-24 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sdamlo | AMLODIPINE | Pangea Pharmaceuticals, LLC | 886a7f97-60a4-4206-a6c7-5206069ed487 | 2025-11-03 | Warnings, Adverse reactions | 219531 NDA219531 |