Application 076688
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | ||
| A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | ||
| A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | ||
| A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076688-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076688-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076688-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076688-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076688-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076688-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076688-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076688-004 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076688-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076688-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076688-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076688-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076688-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076688-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076688-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076688-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076688-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076688-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076688-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076688-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076688-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076688-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076688-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076688-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076688-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076688-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076688-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076688-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076688-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076688-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076688-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076688-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076688-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076688-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076688-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076688-004 | AB | 1 | ea99ee380514… |
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 | Advagen Pharma Ltd | 3f6e6da8-6da3-47c5-a151-e6fd7206890e | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | benazepril hydrochloride and hydrochlorothiazide |
| Benazepril Hydrochloride and Hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | ANI Pharmaceuticals, Inc. | e6527adf-8c74-4d81-9199-d56a7fca895e | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride and Hydrochlorothiazide |
| Benazepril Hydrochloride and Hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | Sandoz Inc | c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f | 2025-06-14 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride and Hydrochlorothiazide |
| benazepril hydrochloride and hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f4120568-dd9b-47a5-bd44-4de6ed343bbe | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | benazepril hydrochloride and hydrochlorothiazide |
| 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 | Benazepril Hydrochloride and Hydrochlorothiazide |
| benazepril hydrochloride and hydrochlorothiazide | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | Padagis US LLC | 3e2d3974-38b0-49d0-8020-f74107584724 | 2023-05-11 | Boxed warning, Warnings, Adverse reactions | benazepril hydrochloride and hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 0378-4725 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4725 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4735 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4735 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4745 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4745 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4775 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4775 | Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8948 | ORIG | 2004-02-12 |