Application 075572

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG	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
A075572-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27
A075572-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27
A075572-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27

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	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075572-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075572-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075572-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-27	`301d65b070ca…`

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 9 · 164 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa4d5cac-f687-4440-99d2-8bb27cf2f4ed	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: BUSPIRONE HYDROCHLORIDE generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	ef90af23-d97e-4094-971b-1d8114218b10	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	801803eb-be17-4064-8813-7ccf52316cde	2026-08-01	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	3155e607-bc7f-4e90-9edf-8e862dd5737d	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	55810b17-4796-49d0-90e4-8e075d62eda4	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fd05160d-24c6-4371-8b2c-c0f78c8b468e	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	bcce49d3-c8eb-9f9b-e053-2995a90a67d9	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Redpharm Drug	5718bc19-07b2-b61d-e063-6394a90a6e80	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	a9fc7091-b3ce-45fd-8d89-aeebdd81c327	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Bucapsol	BUSPIRONE HYDROCHLORIDE	PANGEA PHARMACEUTICALS, LLC	f101c5f3-d533-474d-a8bf-90d054933d16	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Strides Pharma Inc.	cb0091ad-97f6-431b-b2b9-e03171eed274	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	b42cc365-6259-4d2e-9648-d37718b65e1e	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	a9bb9216-3dac-4e8a-9df9-f72c2eaef160	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	IPG Pharmaceuticals, Inc	2c516eec-65d9-4481-8823-ae6b6da84062	2026-06-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
busPIRone HCl	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	472049d2-c4d9-5a38-e063-6294a90a5cf1	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	1d883a13-4877-c6c7-e063-6294a90a5137	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30940	ORIG	2004-05-28
8720	ORIG	2003-04-10