Application 078925
- Type
- ANDA
- Sponsor
- ALKEM
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 |
|---|---|---|---|---|---|---|---|
| A078925-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | |
| A078925-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | |
| A078925-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078925-001 | AB |
| A078925-002 | AB |
| A078925-003 | AB |
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 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078925-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078925-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078925-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078925-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078925-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078925-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078925-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078925-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078925-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078925-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078925-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078925-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078925-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078925-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078925-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078925-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078925-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078925-001 | AB | 1 | 301d65b070ca… |
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 | PD-Rx Pharmaceuticals, Inc. | 47114f60-4151-43d4-ac2d-adc49492a679 | 2025-10-15 | Warnings, Adverse reactions | 078925 ANDA078925 43063-041 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608 | 2025-10-15 | Warnings, Adverse reactions | 078925 ANDA078925 43063-564 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 6cf5ece4-4d4e-478e-be8f-bd198c6edc5d | 2025-09-29 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 921096ab-589a-4821-8d91-a6319f4a559a | 2025-04-09 | Warnings, Adverse reactions | 078925 ANDA078925 50090-2524 50090-2581 50090-1627 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | dc2107cd-edfa-44a6-b139-edee6ccf47ce | 2025-04-08 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 00a037f6-b17f-4d21-9a9a-0e682f68d483 | 2025-04-02 | Warnings, Adverse reactions | 078925 ANDA078925 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719 | 2025-01-17 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | 47f228e9-4a34-4d14-988d-b06af90124b9 | 2025-01-16 | Warnings, Adverse reactions | 078925 ANDA078925 0615-8431 0615-8429 0615-8430 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Quality Care Products, LLC | 6b7c18ef-3a85-4ae3-9135-7ac30a0dde08 | 2024-12-17 | Warnings, Adverse reactions | 078925 ANDA078925 55700-543 55700-541 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 1b449c22-0181-4a50-94b3-26139b90b978 | 2024-08-07 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Ascend Laboratories, LLC | 3f4703c0-0b9e-41a0-8b70-da26683d9ed2 | 2024-06-21 | Warnings, Adverse reactions | 078925 ANDA078925 67877-199 67877-197 67877-198 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | 9c448d87-294e-3325-e053-2a95a90a2299 | 2024-06-20 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | 638d86ab-986b-59ed-e053-2a91aa0a98ee | 2024-06-06 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | ca8c6ca7-79c6-5299-e053-2a95a90a790d | 2024-05-15 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 4512feee-a09d-4244-bc03-c43193e53a0e | 2023-09-20 | Warnings, Adverse reactions | 078925 ANDA078925 50090-5059 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | ced6d26e-8c54-4808-88b6-446344f4acd0 | 2023-06-01 | Warnings, Adverse reactions | 078925 ANDA078925 63187-783 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 445d1274-7249-476b-ad90-ff93aee56f6d | 2022-06-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 9f327d08-7661-4088-b554-2f9a99a113e7 | 2020-10-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8429 | Amlodipine Besylate | Amlodipine besylate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8430 | Amlodipine Besylate | Amlodipine besylate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8431 | Amlodipine Besylate | Amlodipine besylate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 42708-066 | Amlodipine Besylate | Amlodipine besylate | QPharma Inc | ANDA | Current |
| 42708-066 | Amlodipine Besylate | Amlodipine besylate | QPharma Inc | ANDA | Current |
| 42708-066 | Amlodipine Besylate | Amlodipine besylate | QPharma Inc | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-041 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-564 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1627 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1627 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1627 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2524 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2524 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2581 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2581 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2581 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-2581 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 50090-5059 | Amlodipine Besylate | Amlodipine besylate | A-S Medication Solutions | ANDA | Current |
| 53002-2352 | Amlodipine Besylate | Amlodipine besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2352 | Amlodipine Besylate | Amlodipine besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3351 | Amlodipine Besylate | Amlodipine besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-541 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-541 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-541 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-541 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-541 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-543 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-543 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-543 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-543 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-543 | Amlodipine Besylate | Amlodipine besylate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-738 | Amlodipine Besylate | Amlodipine besylate | Quality Care Products, LLC | ANDA | Current |
| 55700-738 | Amlodipine Besylate | Amlodipine besylate | Quality Care Products, LLC | ANDA | Current |
| 60687-477 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-488 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-488 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-488 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-496 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-496 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60687-496 | Amlodipine Besylate | Amlodipine besylate | American Health Packaging | ANDA | Current |
| 60760-614 | Amlodipine Besylate | Amlodipine besylate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-783 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 63187-783 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 63187-783 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 63629-7640 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7640 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 67046-036 | Amlodipine Besylate | Amlodipine besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-036 | Amlodipine Besylate | Amlodipine besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-684 | Amlodipine Besylate | Amlodipine besylate | Contract Pharmacy Services- PA | ANDA | Current |
| 67046-684 | Amlodipine Besylate | Amlodipine besylate | Contract Pharmacy Services- PA | ANDA | Current |
| 67296-1530 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1530 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1530 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1648 | Amlodipine Besylate | Amlodipine besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1648 | Amlodipine Besylate | Amlodipine besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67877-197 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-197 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-197 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-198 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-198 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-198 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-199 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-199 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |