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 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	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.

Product history page 1 of 4 · 129 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
2026-09-14 22:38:34	2026-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075388-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075388-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075388-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-001	AB	1	`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 2 · 25 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	5d93a30e-3544-44e7-ab6a-dc9dc79d7c71	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2409
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 69584-092 ndc (product): 69584-093 ndc (product): 69584-091
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ad651fd5-fd91-4517-8de7-6fafd15ac7eb	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2410
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2a8b3b75-5d93-4a9e-a583-49ccddd65650	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2412
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a738c103-134a-401f-b14c-49a599130b8d	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 63629-2411

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 · 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