Application 017442
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE | Yes | No |
| 002 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE | Yes | No |
| 003 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017442-001 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N017442-002 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N017442-003 | MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017442-001 | AB |
| N017442-002 | AB |
| N017442-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017442-001 | MINIPRESS | EQ 5MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017442-002 | MINIPRESS | EQ 1MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017442-003 | MINIPRESS | EQ 2MG BASE | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N017442-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N017442-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N017442-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N017442-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N017442-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N017442-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N017442-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017442-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017442-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N017442-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017442-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017442-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017442-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017442-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017442-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017442-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017442-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017442-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017442-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017442-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017442-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017442-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017442-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017442-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017442-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017442-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017442-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017442-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017442-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017442-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017442-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017442-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017442-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017442-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017442-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017442-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N017442-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017442-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017442-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017442-001 | AB | 1 | 79d66fd596c7… |
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. | 2f86fc8e-71c1-4749-b67e-86d86cf1d984 | 2026-08-05 | Warnings, Adverse reactions | 017442 NDA017442 70518-3271 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Prasco Laboratories | cbe89216-7dea-43d7-b12e-44ccfb69af3d | 2026-03-06 | Warnings, Adverse reactions | 017442 NDA017442 66993-432 66993-431 66993-433 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-4310 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4310 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4310 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4370 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4370 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4370 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4380 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4380 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4380 | Minipress | prazosin hydrochloride | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 50090-3072 | Prazosin | prazosin hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 59762-5310 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5310 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5310 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5310 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5320 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5320 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5320 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5320 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5350 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5350 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5350 | Prazosin | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5350 | Prazosin Hydrochloride | prazosin hydrochloride | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 66993-431 | Prazosin Hydrochloride | prazosin hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-431 | Prazosin Hydrochloride | prazosin hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-432 | Prazosin Hydrochloride | prazosin hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-433 | Prazosin Hydrochloride | prazosin hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 70518-1884 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1884 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1884 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1884 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1895 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1895 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1895 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1895 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2065 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2065 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2065 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2065 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2065 | Prazosin | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-3271 | Prazosin Hydrochloride | prazosin hydrochloride | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |