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HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |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| HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |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| HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 | |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| HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1994-12-14 |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 HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | Amerisyn LLC | 5a95be60-b242-9183-e063-6394a90a89e6 | 2026-09-03 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | Apnar Pharma LP | 619dd5cb-46fb-4ad9-a05f-f064261a636b | 2026-08-08 | TERAZOSIN HYDROCHLORIDE | |
| Terazosin | TERAZOSIN HYDROCHLORIDE | A-S Medication Solutions | 83bf40fa-6ae1-4811-8dc1-e8c0bcd63d78 | 2026-08-07 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Amerisyn, LLC | 5680d373-0f61-baf8-e063-6394a90ab8a6 | 2026-07-13 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 458b4a60-b2d6-445a-8638-7fcd07decf66 | 2026-06-30 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Amici Pharma, Inc. | 4007dbd3-e850-43e7-8a56-8735e31063cd | 2026-05-20 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | a3a5901a-6395-4030-a27b-1fb17cd97315 | 2026-05-19 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 242589f0-0c79-4ea1-b900-10bccfec2b82 | 2026-05-19 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Jubilant Cadista Pharmaceuticals Inc. | 43e92495-2cf2-46dd-a80c-f0c3c88c7b73 | 2026-05-05 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 2c42171e-1b44-4d34-b6ca-5b6a94f0e694 | 2026-03-10 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | d971811c-d327-4e63-808c-8d553ee471e7 | 2026-03-05 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 854b64ff-c138-45af-9cdf-6c23323d8490 | 2026-01-08 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Coupler LLC | 4614e8cc-c922-4c0f-e063-6394a90a8501 | 2025-12-16 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 3822068f-f160-4493-a207-4d75dad6af73 | 2025-11-05 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | bb88f0d9-e010-4d4d-8465-bcccce0bef6e | 2025-11-05 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin hydrochloride | TERAZOSIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 9d8fd052-b478-447e-a884-74fcd21275bb | 2025-09-30 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 521e4aad-c6ec-4410-867f-dd9ecc08d5b2 | 2025-09-04 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 33699a94-4561-455f-9e5d-48856369aa07 | 2025-09-04 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | AvKARE | a2137488-8554-e84f-e053-2995a90a796c | 2025-07-23 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | AvPAK | 9e7b27a6-cc09-407e-e053-2a95a90a17b3 | 2025-07-02 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |