Application 022026
- Type
- NDA
- Sponsor
- SYNTHON PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 2.5MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022026-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | |
| N022026-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | |
| N022026-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022026-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022026-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022026-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-09-27 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N022026-002 | 6828339 | 2022-11-20 | Drug substance | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N022026-003 | 6828339 | 2022-11-20 | Drug substance | ea99ee380514… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N022026-001 | 6828339 | 2022-11-20 | Drug substance | 3bdfa0b2c4d7… |
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 |
|---|---|---|---|---|---|---|
| Amlodipine Besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | afcffa7b-03b7-499a-b50c-37b0e28c7737 | 2021-05-11 | Warnings, Adverse reactions | Amlodipine Besylate AMLODIPINE BESYLATE |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 9f327d08-7661-4088-b554-2f9a99a113e7 | 2020-10-01 | Warnings, Adverse reactions | Amlodipine Besylate AMLODIPINE BESYLATE |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Cipla USA Inc. | 0c8d6b2f-3e4a-47a2-80e2-a34dcb337555 | 2020-09-09 | Warnings, Adverse reactions | Amlodipine Besylate AMLODIPINE BESYLATE |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Proficient Rx LP | 410aa0a5-43cf-455c-b51d-7dfbc24eee32 | 2020-02-01 | Warnings, Adverse reactions | AMLODIPINE BESYLATE AMLODIPINE BESYLATE |
| Norvasc | AMLODIPINE BESYLATE | PFIZER LABORATORIES DIV PFIZER INC | abd6a2ca-40c2-485c-bc53-db1c652505ed | 2019-01-15 | Warnings, Adverse reactions | AMLODIPINE BESYLATE |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 17e6d552-7528-4597-9498-104cb04f32e7 | 2017-10-25 | Warnings, Adverse reactions | Amlodipine besylate AMLODIPINE BESYLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.