Application 076631
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG | No | No |
| 002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG | No | No |
| 003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG | No | No |
| 004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | |
| A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | RS | 2004-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076631-001 | AB |
| A076631-002 | AB |
| A076631-003 | AB |
| A076631-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | RS | 2004-02-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2004-02-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | AB | 2004-02-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | AB | 2004-02-11 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076631-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076631-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076631-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076631-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076631-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076631-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076631-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076631-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076631-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076631-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076631-004 | AB | 1 | d06236e962d9… |
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 and Hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | Sandoz Inc | c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f | 2025-06-14 | Boxed warning, Warnings, Adverse reactions | 076631 ANDA076631 0185-0211 0185-0236 0185-0325 0185-0277 |
| Benazepril Hydrochloride and Hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | Glenmark Pharmaceuticals Inc., USA | 51b0aed8-a229-4d2c-8fdf-aa957fddc41b | 2023-09-30 | Boxed warning, Warnings, Adverse reactions | 076631 ANDA076631 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0185-0211 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0211 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0211 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0211 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0236 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0236 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0236 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0236 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0277 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0277 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0277 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0277 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0325 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0325 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0325 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0325 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0832-0483 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0483 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0484 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0484 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0485 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0485 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 52959-595 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | H.J. Harkins Company, Inc. | ANDA | Current |
| 63629-1809 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-2680 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-2680 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-2680 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8936 | ORIG | 2004-02-12 |