Application 077516
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 10MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077516-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | 2007-07-11 | ||
| A077516-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | 2007-07-11 | ||
| A077516-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | 2007-07-11 |
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 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | 2007-07-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | 2007-07-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | 2007-07-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | 2007-07-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | 2007-07-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | 2007-07-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077516-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-11 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077516-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077516-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077516-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077516-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077516-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077516-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077516-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077516-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077516-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077516-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077516-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077516-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077516-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077516-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077516-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077516-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077516-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077516-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077516-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077516-001 | AB | 1 | 8072bd15b7f6… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8282 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8282 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8282 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8283 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8283 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8283 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8284 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8284 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8284 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 42582-313 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bi-Coastal Pharma International LLC | ANDA | Current |
| 42582-314 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bi-Coastal Pharma International LLC | ANDA | Current |
| 42582-315 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bi-Coastal Pharma International LLC | ANDA | Current |
| 55700-740 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Quality Care Products, LLC | ANDA | Current |
| 62980-506 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Vivimed Labs Limited | ANDA | Current |
| 62980-507 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Vivimed Labs Limited | ANDA | Current |
| 62980-508 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Vivimed Labs Limited | ANDA | Current |
| 69150-113 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 69150-113 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 69150-114 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 69150-114 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 69150-115 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 69150-115 | Amlodipine Besylate | Amlodipine Besylate | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 71093-146 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-146 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-146 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-146 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-146 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-147 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-147 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-147 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-147 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-147 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-148 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-148 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-148 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-148 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-148 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | ACI Healthcare USA, Inc. | ANDA | Current |
| 71335-1887 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1887 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bryant Ranch Prepack | ANDA | Current |