Application 075579
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 2.5MG;6.25MG | No | No |
| 002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG | No | No |
| 003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;6.25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | |
| A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | |
| A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075579-001 | AB |
| A075579-002 | AB |
| A075579-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075579-001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | 2000-09-25 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075579-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075579-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075579-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075579-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075579-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075579-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075579-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075579-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075579-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075579-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075579-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075579-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075579-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075579-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075579-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075579-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075579-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075579-001 | AB | 1 | 301d65b070ca… |
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.
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 |
|---|---|---|---|---|---|
| 0185-0707 | Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0707 | Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 21695-808 | Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | Rebel Distributors Corp | ANDA | Current |
| 21695-809 | Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | Rebel Distributors Corp | ANDA | Current |
| 63629-4072 | Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |