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BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01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HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01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HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01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A075385-001	BUSPIRONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	2002-03-01	`84e616aacf4f…`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 7 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	Bryant Ranch Prepack	267d8897-90dd-4f8a-bbd8-8aa4e47c2905	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	db32a7ec-5b50-4305-8952-df22e7e871e2	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	APNAR PHARMA LP	3c115eea-9dbc-4e2c-9d79-42e3388fde5a	2024-06-17	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	American Health Packaging	e80d83a6-7c2a-478e-bdf1-c481824fc301	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	19afb386-72a5-c97e-e063-6294a90adaea	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	cff1c7b2-4edb-4b5a-9626-2f7b8671b015	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE	Boswell Pharmacy Services d/b/a BPS Wholesale	18e90d65-4a3a-864e-e063-6294a90ae99d	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	2a25a718-306f-403e-9928-cae30bc52f12	2024-05-06	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a2867dde-e5dd-4cc8-84d0-59240626868a	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eab53fff-c052-4466-a673-3d68aab98c27	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2a8b3b75-5d93-4a9e-a583-49ccddd65650	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a738c103-134a-401f-b14c-49a599130b8d	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	5fa0720f-e236-4b8b-a0c0-6f48037c76b3	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	75b1ae3f-e926-4555-a0e9-50323fc66cb2	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: BUSPIRONE HYDROCHLORIDE generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1886b672-4b88-4b49-ae6a-d2ba2f452e44	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	bce96786-4d9a-460e-8d92-9908ea2af07a	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	a6bdf140-075e-445e-a62d-633a4b97f3a8	2023-12-22	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b07c0a91-892c-47f5-819e-a128e0ef1ed7	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	55e32128-711d-4e95-b58b-e86e0afa4983	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: BUSPIRONE HYDROCHLORIDE generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	d47cde56-e1ab-41fe-832e-d3f33b884a5e	2023-11-28	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