Application 077955
- Type
- ANDA
- Sponsor
- INVAGEN PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A077955-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | |
| A077955-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | |
| A077955-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077955-001 | AB |
| A077955-002 | AB |
| A077955-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-08-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077955-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-08-28 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077955-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077955-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077955-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077955-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077955-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077955-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077955-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077955-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077955-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077955-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077955-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077955-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077955-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077955-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077955-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077955-001 | AB | 1 | 1e350fbaab3a… |
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 | Legacy Pharmaceutical Packaging, LLC | 2cdd0da9-eea6-45e0-b0b7-35413a168a4f | 2026-03-03 | Warnings, Adverse reactions | 077955 ANDA077955 68645-515 68645-516 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | c3742b31-11f6-4c11-98e3-75916a1982d4 | 2024-04-04 | Warnings, Adverse reactions | 077955 ANDA077955 71335-0833 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | f968393f-47d2-4c16-b34f-93a9d61adb9e | 2024-04-04 | Warnings, Adverse reactions | 077955 ANDA077955 71335-0843 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 498a9b21-34b9-4373-930b-5ed43201a345 | 2024-01-09 | Warnings, Adverse reactions | 077955 ANDA077955 63629-1023 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | e8958997-f098-44ce-8c21-b7064d1a962e | 2024-01-09 | Warnings, Adverse reactions | 077955 ANDA077955 63629-1024 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee1 | 2023-09-07 | Warnings, Adverse reactions | 077955 ANDA077955 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | efd9eda5-f497-45a3-ae13-dee729add999 | 2023-03-23 | Warnings, Adverse reactions | 077955 ANDA077955 76282-239 76282-237 76282-238 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Cipla USA Inc. | 0c8d6b2f-3e4a-47a2-80e2-a34dcb337555 | 2020-09-09 | Warnings, Adverse reactions | 077955 ANDA077955 69097-837 69097-838 69097-836 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 17e6d552-7528-4597-9498-104cb04f32e7 | 2017-10-25 | Warnings, Adverse reactions | 077955 ANDA077955 43353-989 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-112 | Amlodipine Besylate | Amlodipine Besylate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-113 | Amlodipine Besylate | Amlodipine Besylate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-600 | Amlodipine Besylate | Amlodipine Besylate | Apotheca Inc. | ANDA | Current |
| 31722-237 | Amlodipine Besylate | Amlodipine Besylate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-238 | Amlodipine Besylate | Amlodipine Besylate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-239 | Amlodipine Besylate | Amlodipine Besylate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 43353-251 | Amlodipine besylate | Amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-251 | Amlodipine besylate | Amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-989 | Amlodipine besylate | Amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-3102 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 51655-053 | Amlodipine Besylate | Amolodipine Besylate | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-054 | Amlodipine Besylate | Amlodipine Besylate | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0200 | Amlodipine Besylate | amlodipine besylate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4985 | Amlodipine Besylate | Amlodipine Besylate | Cardinal Health | ANDA | Current |
| 60687-263 | Amlodipine Besylate | Amlodipine Besylate | American Health Packaging | ANDA | Current |
| 60687-274 | Amlodipine Besylate | Amlodipine Besylate | American Health Packaging | ANDA | Current |
| 60687-285 | Amlodipine Besylate | Amlodipine Besylate | American Health Packaging | ANDA | Current |
| 60760-239 | Amlodipine Besylate | Amlodipine Besylate | St Marys Medical Park Pharmacy | ANDA | Current |
| 61919-295 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Direct Rx | ANDA | Current |
| 61919-295 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Direct Rx | ANDA | Current |
| 63187-197 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-197 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-198 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-198 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63629-1023 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1023 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1023 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1023 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1024 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1024 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1024 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1025 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6631 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6631 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7641 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7641 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7642 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7642 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 64725-0238 | Amlodipine Besylate | Amlodipine Besylate | TYA Pharmaceuticals | ANDA | Current |
| 67046-004 | Amlodipine Besylate | Amlodipine Besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-005 | Amlodipine Besylate | Amlodipine Besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-018 | Amlodipine Besylate | Amlodipine Besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-019 | Amlodipine Besylate | Amlodipine Besylate | Contract Pharmacy Services-PA | ANDA | Current |
| 68151-0995 | Amlodipine Besylate | Amlodipine Besylate | Carilion Materials Management | ANDA | Current |
| 68645-515 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-515 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-515 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-515 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-515 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-516 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-516 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-516 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-516 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-516 | Amlodipine Besylate | Amlodipine Besylate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-9314 | Amlodipine Besylate | Amlodipine Besylate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69097-836 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 69097-836 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 69097-837 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 69097-837 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 69097-838 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 69097-838 | Amlodipine Besylate | Amlodipine Besylate | Cipla USA Inc. | ANDA | Current |
| 71335-0833 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0833 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0833 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0834 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0834 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0843 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0843 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0843 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1032 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1032 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1032 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1397 | Amlodipine besylate | Amlodipine besylate | Bryant Ranch Prepack | ANDA | Current |
| 71610-535 | Amlodipine besylate | Amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76282-237 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-237 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-238 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-238 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-239 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-239 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |