Application 019775
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | No | No |
| 002 | MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019775-001 | MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | ||
| N019775-002 | MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 |
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 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019775-001 | MINIPRESS XL | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019775-002 | MINIPRESS XL | 5MG | TABLET, EXTENDED RELEASE / ORAL | 1992-01-29 | 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 |
|---|---|---|---|---|---|---|
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | e4852fc2-b763-40e2-b8bb-a3f6da5c72fe | 2026-09-03 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | b55790fa-2413-4243-83ec-0391b2effe11 | 2026-09-02 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Major Pharmaceuticals | 4f55f4db-dab3-4e50-9f71-5595fd3ccc12 | 2026-09-01 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | fd860756-9b2e-4bfd-9063-bc4d26366fe6 | 2026-08-26 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 59602472-65d1-4ad8-8dad-a96a0f4cae0c | 2026-08-19 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c8202658-422f-41db-bdee-7bb95b972b32 | 2026-08-17 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e5bd5728-ea7c-4f16-832b-8d58fe14b994 | 2026-08-17 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c4449fa8-a637-4780-8e19-51cb54e1ee68 | 2026-08-17 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 95aa9ffb-66bb-4049-a241-0e1166b4c264 | 2026-08-14 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 8606d9b8-4529-4689-8c93-7114c84c2e54 | 2026-08-14 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 2f86fc8e-71c1-4749-b67e-86d86cf1d984 | 2026-08-05 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | Coupler LLC | 583b4b06-71e4-4696-e063-6294a90a15bf | 2026-08-04 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | a1f5ec80-a9bc-43b0-b3f9-4caaea861cb4 | 2026-07-30 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 4eaa58c1-a5c5-49b4-a8ac-89f12eb29222 | 2026-07-20 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 35c7aa71-6171-4ba5-916c-384c28e5f5c1 | 2026-07-10 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | a3045d80-33f4-4aab-8dce-42fbbf9d3ef7 | 2026-07-07 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 39e3fa5d-ea48-4b02-80f6-44591f5e013f | 2026-07-06 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 558ea3fc-0bfc-32a0-e063-6294a90ae106 | 2026-07-01 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 559082c2-4130-a2bc-e063-6294a90ab781 | 2026-07-01 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 960f4d8d-6683-44ff-a3a7-e0f922e621b9 | 2026-06-11 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.