Application 076118
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 004 | 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 |
|---|---|---|---|---|---|---|---|
| A076118-001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076118-004 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076118-001 | AB |
| A076118-002 | AB |
| A076118-003 | AB |
| A076118-004 | 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 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076118-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076118-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076118-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076118-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076118-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076118-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076118-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076118-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076118-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076118-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076118-004 | AB | 1 | d8e5a09893c0… |
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 | REMEDYREPACK INC. | afd616b9-0c75-48be-862d-5ac18364fd9d | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 01a3c9f6-41aa-47a7-8c56-5462c6b54416 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 032ea0f7-3304-4778-b3a6-6125ea7537ab | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 7aac6a2f-85fb-4c7a-b424-9c253186dffe | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 50090-3243 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 3631d1dc-45e1-0588-e054-00144ff88e88 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 51655-065 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 708110e5-fa45-44e0-9011-261f4490ea45 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 51655-066 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 471cd30a-401a-c8f9-e063-6294a90a4787 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 6c24bb4c-42d2-483a-b33f-95182b32b93d | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 50090-3775 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 8f46e2c9-9b3b-48d0-a307-9069e3879959 | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 50090-0914 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Golden State Medical Supply, Inc. | cb93e793-fe4f-452c-e053-2995a90a7333 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 51407-463 51407-465 51407-462 51407-464 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1a7b373a-9b74-4b9d-93fb-081614222e30 | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 43063-677 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 355811f0-2885-0d49-e054-00144ff8d46c | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 43063-679 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 55c99902-3d4d-05e9-e054-00144ff8d46c | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4d5a8b50-dd2f-4329-9e28-93608e8fe8da | 2025-01-24 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | DIRECT RX | a7e4e43a-7abc-e2a5-e053-2995a90ab5f4 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 08bc0034-3b33-47d8-aec2-b36535ac85a2 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 0653322d-70c6-45f7-a9d1-41efee1d7387 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7274fdaf-1247-2b2f-e053-2991aa0ad3f6 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 700c828c-86c6-1857-e053-2a91aa0ae314 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9535ec77-2d50-4817-e053-2995a90a007e | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-561 | Benazepril Hydrochloride | Benazepril Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 13811-627 | benazepril hydrochloride | Benazepril hydrochloride | Trigen Laboratories, Inc. | ANDA | Current |
| 13811-628 | BENAZEPRIL HYDROCHLORIDE | Benazepril hydrochloride | Trigen Laboratories, Inc. | ANDA | Current |
| 13811-629 | BENAZEPRIL HYDROCHLORIDE | Benazepril hydrochloride | Trigen Laboratories, Inc. | ANDA | Current |
| 13811-630 | BENAZEPRIL HYDROCHLORIDE | Benazepril hydrochloride | Trigen Laboratories, Inc. | ANDA | Current |
| 43063-403 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-677 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-679 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-787 | Benazepril Hydrochloride | Benazepril Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43547-335 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-335 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-335 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-335 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-336 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-336 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-336 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-336 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-337 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-337 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-337 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-337 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-338 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-338 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-338 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 43547-338 | Benazepril Hydrochloride | Benazepril Hydrochloride | Solco healthcare U.S., LLC | ANDA | Current |
| 45865-747 | Benazepril Hydrochloride | Benazepril Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0914 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3243 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3243 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3243 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3243 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3775 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3775 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3775 | Benazepril Hydrochloride | Benazepril Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0337 | Benazepril Hydrochloride | Benazepril Hydrochloride | Unit Dose Services | ANDA | Current |
| 51407-462 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-462 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-463 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-463 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-464 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-464 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-465 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-465 | Benazepril Hydrochloride | Benazepril Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51655-065 | Benazepril HCl | Benazepril HCl | Northwind Pharmaceuticals | ANDA | Current |
| 51655-066 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-067 | Benazepril hydrochloride | Benazepril hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1233 | Benazepril Hydrochloride | Benazepril Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1248 | Benazepril Hydrochloride | Benazepril Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-190 | Benazepril Hydrochloride | Benazepril Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54458-862 | Benazepril Hydrochloride | Benazepril Hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-862 | Benazepril Hydrochloride | Benazepril Hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-863 | Benazepril Hydrochloride | Benazepril Hydrochloride | International Laboratories, LLC | ANDA | Current |
| 54458-863 | Benazepril Hydrochloride | Benazepril Hydrochloride | International Laboratories, LLC | ANDA | Current |
| 55700-290 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-290 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-291 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-291 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-291 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-291 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-317 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-317 | Benazepril Hydrochloride | Benazepril Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-351 | Benazepril Hydrochloride | Benazepril Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-352 | Benazepril Hydrochloride | Benazepril Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-739 | Benazepril | Benazepril | Direct_Rx | ANDA | Current |
| 61919-739 | Benazepril | Benazepril | Direct_Rx | ANDA | Current |
| 61919-756 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63187-393 | Benazepril Hydrochloride | Benazepril Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-393 | Benazepril Hydrochloride | Benazepril Hydrochloride | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31078 | ORIG | 2004-02-12 |