Application 078043
- Type
- ANDA
- Sponsor
- LUPIN
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 |
|---|---|---|---|---|---|---|---|
| A078043-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | |
| A078043-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | |
| A078043-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078043-001 | AB |
| A078043-002 | AB |
| A078043-003 | 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 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | BX | 2007-07-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | BX | 2007-07-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078043-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-07-12 | 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 | A078043-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078043-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078043-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078043-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078043-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078043-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078043-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078043-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078043-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-001 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-002 | BX | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078043-003 | BX | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-001 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-002 | BX | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078043-003 | BX | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-001 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-002 | BX | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078043-003 | BX | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-001 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-002 | BX | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078043-003 | BX | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-001 | BX | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-002 | BX | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078043-003 | BX | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-001 | BX | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-002 | BX | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078043-003 | BX | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078043-001 | 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 | Lupin Pharmaceuticals, Inc. | 003dd1ec-16f8-4f96-b6a8-c4689d35892a | 2026-04-20 | Warnings, Adverse reactions | 078043 ANDA078043 68180-750 68180-720 68180-751 68180-721 68180-752 68180-719 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e0 | 2026-02-26 | Warnings, Adverse reactions | 078043 ANDA078043 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | a6635bb3-b8d5-4046-ac56-27af9bac877e | 2026-02-26 | Warnings, Adverse reactions | 078043 ANDA078043 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | 2437a130-d544-6db4-e063-6394a90a0d4d | 2025-06-13 | Warnings, Adverse reactions | 078043 ANDA078043 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | f18148f9-42b2-43dc-9cf8-212d9121dc5f | 2024-11-01 | Warnings, Adverse reactions | 078043 ANDA078043 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 91e11ca6-05fb-47be-bd40-f8649a35d47d | 2024-10-15 | Warnings, Adverse reactions | 078043 ANDA078043 50090-5355 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 3bd019d3-b58c-44ab-9190-606a0af5e9b6 | 2024-10-14 | Warnings, Adverse reactions | 078043 ANDA078043 50090-5354 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 49d69d27-2a75-4a07-bfb9-24f8af853138 | 2024-10-07 | Warnings, Adverse reactions | 078043 ANDA078043 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5354 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-5354 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-5354 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-5355 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-5355 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-719 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-720 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-721 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-750 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-751 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-752 | Amlodipine Besylate | Amlodipine Besylate | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1597 | Amlodipine Besylate | Amlodipine Besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1597 | Amlodipine Besylate | Amlodipine Besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1914 | Amlodipine Besylate | Amlodipine Besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1914 | Amlodipine Besylate | Amlodipine Besylate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1914 | Amlodipine Besylate | Amlodipine Besylate | REMEDYREPACK INC. | ANDA | Current |