Application 202239
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 2.5MG BASE;10MG | No | No |
| 002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;10MG | No | No |
| 003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;20MG | No | No |
| 004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;40MG | No | No |
| 005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE;20MG | No | No |
| 006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | |
| A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202239-001 | AB |
| A202239-002 | AB |
| A202239-003 | AB |
| A202239-004 | AB |
| A202239-005 | AB |
| A202239-006 | 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 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-005 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-006 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE / ORAL | AB | 2012-09-05 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202239-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202239-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202239-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202239-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202239-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202239-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202239-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202239-004 | AB | 1 | 2680178bc6a6… |
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 and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | AvKARE | fe91d607-5e1f-48e4-e053-6294a90ac522 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b25681a9-7b0e-40f9-844e-ec4842e3713c | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | cb87f119-1598-405f-b627-eec749c8d42c | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f2b56630-4e3a-6f9c-e053-2a95a90a4650 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 02e233c4-48d1-456d-8fc8-f99a06ef854a | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7b5eb6bd-e953-429e-9280-07da4f7d7f47 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 1dd12925-ede8-4ad5-9309-d8c79da1cebf | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 50090-4284 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | DIRECT RX | b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719 | 2025-01-17 | Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | b6eb5283-8e07-47b8-b440-fe72859d8bcc | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 03b175fc-d430-490d-b7ac-9f7a2cb1dd8b | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 57237-145 57237-143 57237-146 57237-147 57237-144 57237-142 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 3de54c49-3590-4a70-9268-fa68e434d923 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 30c401b5-decf-4c0c-8180-92a9b3d7d0fb | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 63629-7535 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | c870013c-e823-4233-a803-33a74f3610a8 | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 99ed4927-9a34-4e8d-8eea-60b63c867d46 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 65862-585 65862-584 65862-582 65862-583 65862-586 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 55bfd9ea-b474-4863-8fae-1b720d91034c | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 50090-3049 50090-2720 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 89d8d490-3a9c-40f2-86b7-94b5101dd09a | 2023-10-26 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | f77db79c-c998-4b63-9984-4cf245f188a7 | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 50090-1042 50090-1418 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 69a887ab-95cd-4b81-80ee-02e20eebf65b | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 50090-3285 50090-3357 |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 29a0d87e-6afb-4766-9045-1963c5b0d183 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 202239 ANDA202239 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33261-982 | Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine Besylate and Benazepril Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-1039 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1042 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1042 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1418 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1418 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1418 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1418 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2720 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2720 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2720 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2720 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3049 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3049 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3285 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3357 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4284 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53002-1782 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 57237-142 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-142 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-142 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-142 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-142 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-143 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-143 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-143 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-143 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-143 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-144 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-144 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-144 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-144 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-144 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-145 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-145 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-145 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-145 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-145 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-146 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-146 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-146 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-146 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-146 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-147 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-147 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-147 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-147 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-147 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Rising Health, LLC | ANDA | Current |
| 61919-852 | AMOLDIPINE BENAZEPRIL HCL | AMOLDIPINE BENAZEPRIL HCL | DirectRX | ANDA | Current |
| 63629-7535 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7535 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7535 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7535 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7535 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7998 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7998 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7998 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 65862-582 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-582 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-582 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-582 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-582 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-583 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-583 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-583 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-583 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-583 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-584 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-584 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-584 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-584 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-584 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-585 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-585 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-585 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-585 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-585 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-586 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-586 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-586 | Amlodipine and Benazepril Hydrochloride | Amlodipine and Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |