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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076118-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076118-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2004-02-11 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076118-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076118-004 | AB | 1 | 84e616aacf4f… |
| 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… |
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 | NuCare Pharmaceuticals, Inc. | 53fea330-cc4a-3b7e-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | be41d21c-4747-47bb-b4b7-bbfabcd7a9b1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 63187-393 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Solco healthcare U.S., LLC | bb91223e-ffa5-4a3a-b191-fe121250c20c | 2024-06-30 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 43547-338 43547-335 43547-336 43547-337 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 99755c59-18b9-ab7b-e053-2a95a90a4155 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9987a842-07a5-635e-e053-2995a90afa32 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | ebdf5144-752d-456f-b46d-19cbba0bc3d7 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | b0d3122a-5332-4af6-98d8-520ed70ace62 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 313225d7-f947-40b3-96d7-289aad300a4a | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 076118 ANDA076118 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |