Application 078212
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078212-001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | |
| A078212-002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | |
| A078212-003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078212-001 | AB |
| A078212-002 | AB |
| A078212-003 | 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 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-002 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-003 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | RS | 2008-05-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078212-001 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-22 | 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 | A078212-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078212-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078212-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078212-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078212-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078212-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078212-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078212-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078212-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078212-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078212-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078212-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078212-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078212-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078212-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078212-001 | 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 |
|---|---|---|---|---|---|---|
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 58977ec4-36ea-4d81-a8f0-7298425cbc84 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 71335-1365 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 43063-748 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 09e383a8-e912-4cf7-8fb3-05545af80dd0 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 65862-116 65862-118 65862-117 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 67c64de1-5579-46e4-82ee-c9bbee708e02 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f7f9dc46-a947-7ae3-e053-6394a90a1192 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | fc4cd253-13ee-9424-e053-6394a90a35a8 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f32d01db-655b-f3d0-e053-2a95a90a04f6 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | fade97e1-8400-4214-b750-e7656cae7a0f | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 50090-5751 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 91a3d0f7-d2df-4230-ad9e-b32f7312d337 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9016634a-1bdd-700d-e053-2995a90a8f27 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 68071-5028 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 800f2a14-98b9-3499-e053-2991aa0a197d | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 68071-4722 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | e0d5362b-f5da-4838-ae91-22f40fcca245 | 2023-12-03 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 50090-5750 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | c5090372-41bf-4677-b198-97fd55a0cb87 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 50090-3359 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 92a26516-3d84-4d7a-a770-523926507887 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 078212 ANDA078212 71205-320 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-748 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3359 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3359 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5750 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5751 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5751 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 65862-116 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-116 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-116 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-116 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-117 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-117 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-117 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-117 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-118 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-118 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-118 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-118 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4722 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4722 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4722 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4890 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4890 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5028 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5028 | Benazepril Hydrochloride | Benazepril Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7248 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7248 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7845 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticlas Inc. | ANDA | Current |
| 68788-7845 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticlas Inc. | ANDA | Current |
| 68788-7845 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticlas Inc. | ANDA | Current |
| 68788-7846 | Benazepril Hydrochloride | Benazepril Hydrochloride | Preferred Pharmaceuticlas Inc. | ANDA | Current |
| 70518-3074 | Benazepril Hydrochloride | Benazepril Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3171 | Benazepril Hydrochloride | Benazepril Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3172 | Benazepril Hydrochloride | Benazepril Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-983 | Benazepril Hydrochloride | Benazepril Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-983 | Benazepril Hydrochloride | Benazepril Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-320 | Benazepril Hydrochloride | Benazepril Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1365 | Benazepril Hydrochloride | Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1365 | Benazepril Hydrochloride | Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1365 | Benazepril Hydrochloride | Benazepril Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44378 | ORIG | 2008-05-30 |