Application 019057
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYTRIN | TERAZOSIN HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | HYTRIN | TERAZOSIN HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No |
| 003 | HYTRIN | TERAZOSIN HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 004 | HYTRIN | TERAZOSIN HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019057-001 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | ||
| N019057-002 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | ||
| N019057-003 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | ||
| N019057-004 | HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019057-001 | HYTRIN | EQ 1MG BASE | TABLET / ORAL | 1987-08-07 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019057-002 | HYTRIN | EQ 2MG BASE | TABLET / ORAL | 1987-08-07 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019057-003 | HYTRIN | EQ 5MG BASE | TABLET / ORAL | 1987-08-07 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019057-004 | HYTRIN | EQ 10MG BASE | TABLET / ORAL | 1987-08-07 | 74a2ff9319b5… |
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 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 | 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 | 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 |
| Terazosin | TERAZOSIN HYDROCHLORIDE | A-S Medication Solutions | 4b195327-10d4-477f-ada2-d62c7f835e6c | 2024-11-07 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 214d9b06-8d23-3ee8-e063-6394a90a1521 | 2024-09-04 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
| Terazosin | TERAZOSIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 40e5ae44-708a-15a3-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | TERAZOSIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.