Application 075385

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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
A075385-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01
A075385-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01
A075385-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01

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	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075385-002	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075385-003	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`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 2 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	Unit Dose Solutions, Inc.	544a4570-bd7f-72bb-e063-6394a90ab8d6	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544b8918-7175-655f-e063-6394a90a453a	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fbff8248-b73c-474e-907e-449f8316c629	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	53e7576a-e2f4-042b-e063-6294a90ae035	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	66df7f74-5dea-46d6-9ef8-9bab37baf407	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	225575f1-9635-4922-8286-d479d6480bf0	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eee7fa99-a9a1-4299-8a3d-6c2dd90948c9	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Asclemed USA, Inc.	97f2d082-0931-4e4f-a5be-7792e399e42b	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	510120d3-c922-a071-e063-6294a90af6a7	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	50b18368-d37c-374b-e063-6394a90a8114	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	1315494d-7a51-4395-bc7c-afb4bc5482c9	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	5b4da3f8-a5ce-4699-92e1-37fb95e0af2d	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	5424f933-93e1-4480-acdf-bd8667ae50e9	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	093b701d-4a43-4871-b726-c5820fa3ab95	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
busPIRone HCl	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	138b84a5-966b-47d7-a3d6-395df83f8aa5	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	6c6db7a9-a728-406a-81af-edd89e1cc26f	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	459cc50d-0b18-ac1d-e063-6294a90ae7c4	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	824c80e6-d508-405f-8a4f-2f10df5a9dc8	2026-03-20	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.

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
0615-4575	Buspirone Hydrochloride	Buspirone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4595	Buspirone Hydrochloride	Buspirone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4596	Buspirone Hydrochloride	Buspirone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8641	ORIG	2004-05-28
30868	ORIG	2003-04-10