Application 020186
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG | Yes | No |
| 002 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;6.25MG | Yes | Yes |
| 003 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 2.5MG;6.25MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020186-001 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 |
| N020186-002 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 |
| N020186-003 | ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020186-001 | AB |
| N020186-002 | AB |
| N020186-003 | 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 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020186-002 | ZIAC | 10MG;6.25MG | TABLET / ORAL | AB | RLD, RS | 1993-03-26 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020186-003 | ZIAC | 2.5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020186-001 | ZIAC | 5MG;6.25MG | TABLET / ORAL | AB | RLD | 1993-03-26 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020186-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020186-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020186-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020186-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020186-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020186-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020186-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020186-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020186-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020186-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020186-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020186-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020186-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020186-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020186-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020186-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020186-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020186-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020186-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020186-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020186-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020186-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020186-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020186-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020186-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020186-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020186-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020186-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020186-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020186-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020186-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020186-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020186-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020186-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020186-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020186-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020186-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020186-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020186-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020186-002 | AB | 1 | 3f01610625f2… |
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 |
|---|---|---|---|---|---|---|
| bisoprolol fumarate and hydrochlorothiazide | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | 27d52b23-e3e2-4339-b00e-cd0fec43ffbb | 2026-08-11 | Warnings, Adverse reactions | 020186 NDA020186 0093-3243 0093-3241 0093-3242 |
| bisoprolol fumarate and hydrochlorothiazide | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | cf088009-203e-4d70-b56e-b4062cf3fcd8 | 2023-05-19 | Warnings, Adverse reactions | 020186 NDA020186 |
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 |
|---|---|---|---|---|---|
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3241 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3242 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-3243 | bisoprolol fumarate and hydrochlorothiazide | bisoprolol fumarate and hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-040 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-047 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
| 51285-050 | Ziac | bisoprolol fumarate and hydrochlorothiazide | Teva Women's Health, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77159 | SUPPL | 2023-12-27 |
| 77133 | SUPPL | 2023-12-27 |
| 66727 | SUPPL | 2021-03-10 |
| 66465 | SUPPL | 2021-03-03 |
| 64385 | SUPPL | 2020-08-24 |
| 64344 | SUPPL | 2020-08-21 |
| 34355 | SUPPL | 2011-05-05 |
| 12309 | SUPPL | 2010-08-12 |
| 24553 | SUPPL | 2010-01-19 |
| 34354 | SUPPL | 2009-11-19 |
| 24552 | SUPPL | 2007-09-26 |
| 24551 | SUPPL | 2004-07-01 |
| 41210 | SUPPL | 2001-08-01 |