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 | Coupler LLC | 5358bc3c-912c-bba4-e063-6394a90a4457 | 2026-06-03 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Coupler LLC | 52ce82b0-3cb5-b5b2-e063-6394a90a9f12 | 2026-05-27 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 511b4409-7273-4b74-ae55-47c97f0c3ea4 | 2026-05-19 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Coupler LLC | 518c9848-bf84-9742-e063-6394a90aea2f | 2026-05-11 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Coupler LLC | 5103a3cc-e88f-df52-e063-6294a90aec78 | 2026-05-04 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Safecor Health LLC | 12cdde5b-173c-4f31-a326-3128d521930c | 2026-04-09 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Prasco Laboratories | cbe89216-7dea-43d7-b12e-44ccfb69af3d | 2026-03-06 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Cardinal Health 107, LLC | 6209ae19-7ea0-437d-8e5d-12e37917ed13 | 2026-02-26 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4870901f-5277-e6c0-e063-6394a90a1d3c | 2026-01-15 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4870ed0b-abde-5ae5-e063-6394a90ad0ba | 2026-01-15 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Marlex Pharmaceuticals Inc | 1c28c337-6dbb-46bd-aa86-dbcd34e3f6e6 | 2025-11-21 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Cardinal Health 107, LLC | 879df2f9-d238-4cde-bbf8-82aef20fde3b | 2025-10-24 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | Biocon Pharma Inc. | 82a84f69-4742-453f-96c8-532fb7df44c6 | 2025-10-23 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e5e129aa-2ee3-4c12-a327-5d5382cf2310 | 2025-10-21 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5d7dff44-84b1-4044-bc5a-c76ea11dd5a3 | 2025-10-21 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | cd52f022-ca29-4f87-8684-da63e05b3c1f | 2025-10-21 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | ASCLEMED USA INC. | b66d105b-be78-4e54-9c01-b38e36ad74de | 2025-10-15 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Mylan Institutional Inc. | e6a029b2-802f-4cc5-8795-20e177e8d779 | 2025-07-22 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | fa00e99e-f050-4544-a11b-d20c9710761e | 2025-07-03 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
| prazosin hydrochloride | PRAZOSIN HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 35a996a5-abba-838d-e063-6294a90a72a4 | 2025-05-21 | Warnings, Adverse reactions | PRAZOSIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.