Application 075388

Type: ANDA
Sponsor: OXFORD 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 1.

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
A075388-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09
A075388-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09
A075388-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075388-001	AB
A075388-002	AB
A075388-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075388-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	8e0219e9-d305-4473-8229-aee0ee84caf6	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 72789-139 ndc (product): 72789-140 ndc (product): 72789-141
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	84621631-4c13-4147-ae3c-4ed30d4ebb37	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	3155e607-bc7f-4e90-9edf-8e862dd5737d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 70518-2987
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	338f3317-96c0-4b8a-8299-8ce2a10911ae	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	e4d44e49-eb8f-454e-a737-22caf30bda78	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	49659ee7-ca08-4df1-8e6b-3a366a7839c7	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	bee0edbf-3fc3-484b-9715-f13a329216ae	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	40d5813d-d040-002c-e063-6294a90a5f7a	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7c7225a0-8237-4998-843a-bf10fa6ec65b	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2df0b238-14a4-40ca-a235-411f6c9b8338	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 71335-1938
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	f85b59b7-b945-4440-8378-987bd287a655	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 71335-1752
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b217f341-7d51-475d-887f-f16786164c7b	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 72789-181
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	270398a0-21b8-407b-af76-4aeef90f72be	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dd7f213-afd8-67d6-e063-6294a90ac108	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	65c69118-36bb-4f0d-9669-b52556056ec5	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2413
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ed7e334a-cc4a-47b2-a4db-56495730b698	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2408

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2408	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2408	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2409	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2409	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2410	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2410	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2411	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2411	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2412	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2412	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2413	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2413	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-7875	Buspirone Hydrochloride	buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7875	Buspirone Hydrochloride	buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
69584-091	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-091	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-091	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-092	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-092	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-092	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-093	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-093	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-093	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
70518-2987	Buspirone Hydrochloride	buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1752	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1752	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1938	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1938	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-139	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-139	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-139	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-140	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-140	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-140	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-141	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-141	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-141	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-181	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-181	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-181	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-181	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current