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 3 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	ST. MARY'S MEDICAL PARK PHARMACY	35a9c70d-b611-cf9d-e063-6294a90a23f7	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	486d4f26-60ae-4e6c-aa36-0b298a7f9aed	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler, LLC	30b70064-79e1-b8a9-e063-6394a90a69cb	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	American Health Packaging	2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf4	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	American Health Packaging	a2b84746-f780-4e21-adc9-62d09c9363cf	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f8fd7e1d-471d-f4ae-e053-6294a90a8b41	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d01b8927-a422-43b3-89de-088506fdee3c	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	18680157-a123-1072-e063-6394a90ad5ef	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	2a928735-179f-4637-8c4e-3b5e01d45bf2	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	61e5108a-70eb-4d48-a742-defb2e918b63	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	d58fd197-ca7a-481b-bf3c-0babb80db023	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	ce926a30-d417-4fc1-8aa3-71405f09ec5e	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f475c5e7-94df-40c8-b35f-ce6f866ed1b9	2023-12-21	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	A-S Medication Solutions	8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	bf6dbac4-a3d4-4689-8e74-072362328cd3	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	d7a9f9c3-fbb7-421e-ab65-fdd805a3197f	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	b8a9cbee-c526-4d1e-ad2f-cf7fbb784936	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: prazosin hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	d4af73d1-c97e-4418-9e24-007b10af0bd9	2023-05-12	Warnings, Adverse reactions	Name fallback brand name: PRAZOSIN HYDROCHLORIDE generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	08114092-fa12-4f58-b08e-03cadf9f726b	2023-04-04	Warnings, Adverse reactions	Name fallback brand name: Prazosin Hydrochloride generic name: PRAZOSIN HYDROCHLORIDE
Prazosin Hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0	2023-04-03	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