Application 019775

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

Matched openFDA labels page 4 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d33bb132-1b5f-44a2-bc42-e9201cb6566a	2023-03-20	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Lifestar Pharma LLC	73bbc360-5bfb-4139-a63e-0cb6e4ea8313	2023-03-17	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	fea187a3-ee8b-4463-8485-3b1de1504609	2023-03-10	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Exelan Pharmaceuticals	cdde7b22-6b29-4cac-8bd6-f613dab6eef1	2023-01-26	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1ce90aaf-d075-4617-9a47-e8d922096d23	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	7293cef3-ef9e-40dc-9995-875ef047f693	2018-10-25	Warnings, Adverse reactions	Name fallback generic name: PRAZOSIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.