Application 072577

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 2MG BASE	No	No
002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 1MG BASE	No	No
003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE	No	No

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

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	Approval date
A072577-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16
A072577-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16
A072577-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16

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 4 · 129 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	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072577-002	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	1989-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072577-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	1989-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072577-001	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	1989-05-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072577-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072577-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072577-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072577-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072577-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072577-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A072577-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072577-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072577-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072577-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072577-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072577-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072577-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072577-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072577-003	AB	1	`87673890dc5c…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072577-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072577-002	AB	1	`cb3db0bc1861…`

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 4 · 66 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	b55790fa-2413-4243-83ec-0391b2effe11	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Major Pharmaceuticals	4f55f4db-dab3-4e50-9f71-5595fd3ccc12	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	fd860756-9b2e-4bfd-9063-bc4d26366fe6	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	59602472-65d1-4ad8-8dad-a96a0f4cae0c	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c8202658-422f-41db-bdee-7bb95b972b32	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e5bd5728-ea7c-4f16-832b-8d58fe14b994	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c4449fa8-a637-4780-8e19-51cb54e1ee68	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	95aa9ffb-66bb-4049-a241-0e1166b4c264	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	8606d9b8-4529-4689-8c93-7114c84c2e54	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	2f86fc8e-71c1-4749-b67e-86d86cf1d984	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	583b4b06-71e4-4696-e063-6294a90a15bf	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a1f5ec80-a9bc-43b0-b3f9-4caaea861cb4	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	4eaa58c1-a5c5-49b4-a8ac-89f12eb29222	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35c7aa71-6171-4ba5-916c-384c28e5f5c1	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	a3045d80-33f4-4aab-8dce-42fbbf9d3ef7	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	39e3fa5d-ea48-4b02-80f6-44591f5e013f	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	558ea3fc-0bfc-32a0-e063-6294a90ae106	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	559082c2-4130-a2bc-e063-6294a90ab781	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	960f4d8d-6683-44ff-a3a7-e0f922e621b9	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-580	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-580	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-580	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-581	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-581	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-581	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-582	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-582	Prazosin Hydrochloride	Prazosin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
70518-3383	Prazosin Hydrochloride	Prazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1932	Prazosin Hydrochloride	Prazosin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2042	Prazosin Hydrochloride	Prazosin Hydrochloride	Bryant Ranch Prepack	ANDA	Current