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 | NCS HealthCare of KY, LLC dba Vangard Labs | 6efc0ef6-0424-44fc-a9ea-eb30c3b83239 | 2026-09-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | QPharma, Inc. | 5866d1ee-631d-d09e-e063-6294a90abe01 | 2026-08-20 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | American Health Packaging | 79f41cd2-6d58-4b03-8b0c-ca91398bc1a9 | 2026-08-17 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 58a67272-c4c7-4e2c-85a5-9d39034d12c3 | 2026-07-27 | Warnings, Adverse reactions | 078925 ANDA078925 70518-2632 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 4ad016ec-e158-4325-9f45-4460cf78dd98 | 2026-07-16 | Warnings, Adverse reactions | 078925 ANDA078925 70518-1971 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unit Dose Solutions, Inc. | 5467eee5-1519-7859-e063-6294a90afed1 | 2026-06-16 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 61cb7f91-d1f6-40bd-98a3-c461098a20d9 | 2026-06-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Coupler LLC | 2904c6e1-2c51-8035-e063-6294a90aa04b | 2026-05-13 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 72dafc2f-5266-442b-914a-61d1ef1f7ab8 | 2026-04-29 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | d2f66b58-78ec-456b-8397-2120a223827c | 2026-04-28 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | cd305e6e-9107-4d25-9918-8d0d9b9ba1ca | 2026-04-24 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 50204e86-a345-4d2f-b62f-a548787e197f | 2026-04-24 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals, Inc. | 01139e81-a4fa-4e13-acdf-c75c79a1aa9c | 2026-02-23 | Warnings, Adverse reactions | 078925 ANDA078925 68788-9345 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 1ff04bd2-9926-48a4-9afc-eab0789dba01 | 2026-02-23 | Warnings, Adverse reactions | 078925 ANDA078925 68788-8263 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 204f27e9-5041-4677-b313-866ca69abad9 | 2026-02-13 | Warnings, Adverse reactions | 078925 ANDA078925 70518-2981 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 6e038d92-09f3-4517-947e-146d007114b8 | 2026-01-14 | Warnings, Adverse reactions | 078925 ANDA078925 68788-7985 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | f2b8274b-d849-6793-e053-2a95a90aa0e8 | 2026-01-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | f32bb322-68d7-a4ca-e053-2995a90aa7b0 | 2026-01-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Ascend Laboratories, LLC | 2b0bcb95-dc85-46f7-8b69-ca55cd58b30e | 2025-12-10 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | QPharma Inc | 3f74ed2b-4712-4026-ac2c-9239a211dde3 | 2025-12-05 | 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 |
|---|---|---|---|---|---|
| 67877-199 | Amlodipine Besylate | Amlodipine besylate | Ascend Laboratories, LLC | ANDA | Current |
| 68071-2415 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2520 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4251 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4251 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4251 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4251 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4251 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4776 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4776 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4776 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5151 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5151 | Amlodipine Besylate | Amlodipine besylate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7985 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7985 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8263 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9345 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9345 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9345 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9345 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9345 | Amlodipine Besylate | Amlodipine besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1971 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1971 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1971 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1971 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1971 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2632 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2632 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2632 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2632 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2632 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2981 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2981 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2981 | Amlodipine Besylate | Amlodipine besylate | REMEDYREPACK INC. | ANDA | Current |
| 70934-075 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-075 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-075 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-075 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-330 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-330 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-330 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-330 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-434 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-434 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-920 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-920 | Amlodipine Besylate | Amlodipine besylate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-488 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 71205-596 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 71205-596 | Amlodipine Besylate | Amlodipine besylate | Proficient Rx LP | ANDA | Current |
| 71335-0890 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0890 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0890 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0934 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0934 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0934 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0945 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0945 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0945 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0946 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0946 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1278 | Amlodipine Besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 72189-162 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 72189-162 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 72789-082 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-082 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-082 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-082 | Amlodipine Besylate | Amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |