Application 215697

Type: ANDA
Sponsor: MANKIND PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 1MG BASE	No	No
002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 2MG 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 42.

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	Approval date
A215697-001	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30
A215697-002	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30
A215697-003	PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215697-001	AB
A215697-002	AB
A215697-003	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 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-002	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-003	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2022-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215697-001	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2022-12-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215697-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215697-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215697-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215697-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215697-001	AB	1	`1e350fbaab3a…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	95aa9ffb-66bb-4049-a241-0e1166b4c264	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	8606d9b8-4529-4689-8c93-7114c84c2e54	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler LLC	583b4b06-71e4-4696-e063-6294a90a15bf	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ASCLEMED USA INC.	b66d105b-be78-4e54-9c01-b38e36ad74de	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	REMEDYREPACK INC.	e4852fc2-b763-40e2-b8bb-a3f6da5c72fe	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e5bd5728-ea7c-4f16-832b-8d58fe14b994	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	fa00e99e-f050-4544-a11b-d20c9710761e	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a996a5-abba-838d-e063-6294a90a72a4	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a9c70d-b611-cf9d-e063-6294a90a23f7	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Coupler, LLC	30b70064-79e1-b8a9-e063-6394a90a69cb	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	fb6db16d-3768-631b-e053-6294a90a1cee	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f8fd7e1d-471d-f4ae-e053-6294a90a8b41	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	f6c9eef9-c016-9020-e053-6294a90a1cd8	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
Prazosin HCL	PRAZOSIN HCL	Direct_Rx	13018fa7-5e30-ed92-e063-6394a90a4427	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	2a928735-179f-4637-8c4e-3b5e01d45bf2	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	61e5108a-70eb-4d48-a742-defb2e918b63	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Bryant Ranch Prepack	f475c5e7-94df-40c8-b35f-ce6f866ed1b9	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Proficient Rx LP	b8a9cbee-c526-4d1e-ad2f-cf7fbb784936	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697
prazosin hydrochloride	PRAZOSIN HYDROCHLORIDE	Lifestar Pharma LLC	73bbc360-5bfb-4139-a63e-0cb6e4ea8313	2023-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215697 application number: ANDA215697 ndc (product): 70756-429 ndc (product): 70756-440 ndc (product): 70756-430

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70756-429	prazosin hydrochloride	prazosin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-430	prazosin hydrochloride	prazosin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-440	prazosin hydrochloride	prazosin hydrochloride	Lifestar Pharma LLC	ANDA	Current