Application 020347
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYTRIN | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | HYTRIN | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | HYTRIN | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | HYTRIN | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020347-001 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |
| N020347-002 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |
| N020347-003 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |
| N020347-004 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 |
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 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020347-001 | HYTRIN | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020347-002 | HYTRIN | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020347-003 | HYTRIN | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020347-004 | HYTRIN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | 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 |
|---|---|---|---|---|---|---|
| Terazosin | TERAZOSIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 40e5ae44-708a-15a3-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 363a6c85-e5e9-4521-9065-37a7c45bb525 | 2024-02-06 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 85e450c2-1bc3-49f4-ac2b-5aeedc154bba | 2024-02-01 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 0574d9ae-04da-4cb2-b124-9d920012c411 | 2023-07-20 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2f2db826-182d-4dd1-af97-f874b57b1fb9 | 2023-06-15 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 9199083d-403f-4c9e-90e1-713ed0a07903 | 2023-04-05 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Proficient Rx LP | 27f8952a-189d-4687-854e-c51da619bf3d | 2022-10-01 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Proficient Rx LP | 6cbd8853-718d-42ba-bc27-e3983eefb804 | 2022-10-01 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e5507ea6-bdb3-4363-a68b-0478cbb25f4a | 2021-08-26 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 81d5422c-ff57-4f6d-927c-5de4dd7e1169 | 2021-01-22 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 0d7779b3-02c5-4a74-a749-82ed6ae2c9bc | 2020-11-12 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.