Application 017442

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
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#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
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.

Product history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017442-001	MINIPRESS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017442-002	MINIPRESS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017442-003	MINIPRESS	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017442-001	MINIPRESS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017442-002	MINIPRESS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017442-003	MINIPRESS	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017442-001	MINIPRESS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017442-002	MINIPRESS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017442-003	MINIPRESS	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017442-001	MINIPRESS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017442-002	MINIPRESS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017442-003	MINIPRESS	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 017442 application number: NDA017442 ndc (product): 70518-3271
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Prasco Laboratories	cbe89216-7dea-43d7-b12e-44ccfb69af3d	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017442 application number: NDA017442 ndc (product): 66993-432 ndc (product): 66993-431 ndc (product): 66993-433

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13140	SUPPL	2015-03-02
10991	SUPPL	2015-03-02
13139	SUPPL	2013-11-07
10990	SUPPL	2013-11-04
10989	SUPPL	2009-07-23
13138	SUPPL	2009-07-15
33269	SUPPL	2009-04-16
13137	SUPPL	2009-04-09
587	SUPPL	2001-06-12