Application 203245
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A203245-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203245-001 | AB |
| A203245-002 | AB |
| A203245-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203245-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203245-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203245-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203245-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203245-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203245-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203245-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203245-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203245-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203245-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203245-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203245-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203245-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203245-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203245-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amlodipine Besylate | AMLODIPINE BESYLATE | ST. MARY'S MEDICAL PARK PHARMACY | b2d5cccd-e5ff-2909-e053-2a95a90a9773 | 2026-05-22 | Warnings, Adverse reactions | 203245 ANDA203245 60760-445 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 988e5acb-356e-4116-b6db-ab8468ed7234 | 2026-04-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 743ae641-14e1-456b-80e6-c6f7d621e969 | 2026-01-16 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | 0de6a6d0-a114-e114-e063-6394a90a34dd | 2025-12-26 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 41af64c4-b788-d827-e063-6394a90a9157 | 2025-10-21 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 3e0fbf93-cc64-4fa5-b586-c2020614c884 | 2025-09-03 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 0c7d1f99-dfe0-7041-e063-6294a90a9705 | 2025-07-11 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Redpharm Drug | fc61eee9-ee15-9078-e053-6394a90a22f4 | 2025-01-23 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Quality Care Products, LLC | a75e4797-6b7f-4366-9105-79d6877adac5 | 2024-12-19 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 699d3ba2-a342-4e3d-b8ad-c14e0df64dfe | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | da4e36d3-1ddc-4350-9a00-86975e523f75 | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | b1151904-5085-49bd-94ec-cb2894f4eb10 | 2024-08-22 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | b4cc6d7e-923b-e81c-e053-2995a90a0731 | 2024-07-17 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 094498f2-11d9-2a05-e063-6294a90ab2e1 | 2024-06-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5a67bbdc-ac1f-4778-bbdc-929df140b7f5 | 2024-06-10 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 52daa759-3327-461a-8cfc-3c6253df91ec | 2024-03-05 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5c50c3fe-afe5-459e-95c0-c9af4cbb6909 | 2023-11-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unichem Pharmaceuticals (USA), Inc. | a516b336-8f60-4b86-8921-c7d6c07629f2 | 2022-12-05 | Warnings, Adverse reactions | 203245 ANDA203245 29300-397 29300-396 29300-398 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6 | 2022-04-01 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | c2c51ec3-ffb0-4240-b048-a8e424775a76 | 2021-08-01 | Warnings, Adverse reactions | 203245 ANDA203245 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-0210 | Amlodipine Besylate | Amlodipine Besylate | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0211 | Amlodipine Besylate | Amlodipine Besylate | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0213 | Amlodipine Besylate | Amlodipine Besylate | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0615-8199 | Amlodipine Besylate | Amlodipine Besylate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8200 | Amlodipine Besylate | Amlodipine Besylate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8201 | Amlodipine Besylate | Amlodipine Besylate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 12634-562 | Amlodipine Besylate | Amlodipine Besylate | Apotheca Inc. | ANDA | Current |
| 12634-599 | Amlodipine Besylate | Amlodipine Besylate | Apotheca Inc. | ANDA | Current |
| 29300-241 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-241 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-241 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-241 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-242 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-242 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-242 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-242 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-243 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-243 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-243 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-243 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-396 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-396 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-396 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-396 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-397 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-397 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-397 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-397 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-398 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-398 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-398 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-398 | Amlodipine Besylate | Amlodipine Besylate | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 45865-617 | Amlodipine Besylate | Amlodipine Besylate | Medsource Pharmaceuticals | ANDA | Current |
| 50090-1404 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1404 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1404 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1404 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1527 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1527 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1527 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1529 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1529 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-1529 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 50090-4903 | Amlodipine Besylate | Amlodipine Besylate | A-S Medication Solutions | ANDA | Current |
| 51655-052 | Amlodipine Besylate | Amlodipine Besylate | Northwind Pharmaceuticals | ANDA | Current |
| 51655-052 | Amlodipine Besylate | Amlodipine Besylate | Northwind Pharmaceuticals | ANDA | Current |
| 53002-2249 | Amlodipine Besylate | Amlodipine Besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2249 | Amlodipine Besylate | Amlodipine Besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2351 | Amlodipine Besylate | Amlodipine Besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2351 | Amlodipine Besylate | Amlodipine Besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3249 | Amlodipine Besylate | Amlodipine Besylate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 60760-445 | Amlodipine Besylate | Amlodipine Besylate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-459 | Amlodipine Besylate | Amlodipine Besylate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Direct_Rx | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Direct_Rx | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-782 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | ANDA | Current |
| 61919-844 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DirectRX | ANDA | Current |
| 61919-844 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Direct_Rx | ANDA | Current |
| 61919-844 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DirectRX | ANDA | Current |
| 63187-326 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-326 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-508 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-508 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63187-508 | Amlodipine Besylate | Amlodipine Besylate | Proficient Rx LP | ANDA | Current |
| 63629-8023 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8023 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8023 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8024 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8024 | Amlodipine Besylate | Amlodipine Besylate | Bryant Ranch Prepack | ANDA | Current |
| 67296-1529 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1529 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1529 | Amlodipine Besylate | Amlodipine Besylate | RedPharm Drug, Inc. | ANDA | Current |