Application 078302

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	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078302-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2007-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078302-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078302-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078302-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078302-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078302-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078302-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078302-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078302-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078302-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078302-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078302-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078302-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078302-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078302-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078302-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078302-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078302-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078302-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078302-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078302-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078302-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078302-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078302-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078302-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078302-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078302-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078302-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078302-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078302-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078302-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078302-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078302-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078302-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078302-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078302-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078302-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078302-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078302-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078302-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078302-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078302-001	AB	1	`e64feba35796…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 72789-142
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eb072818-3ca8-430b-91a1-e7fedd37990c	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	38677cd0-2ee6-4c8f-8553-36310b2813a1	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	790b6159-c03b-4a3a-be6b-add35a3114a4	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 69584-094
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	696911d8-e97a-4c8e-9341-782b4c63bf03	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 63629-2415
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8bb7991e-ab09-4602-b49d-0a72a501685b	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 63629-2414

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2414	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2414	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2415	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2415	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
69584-094	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-094	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-094	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-094	Buspirone Hydrochloride	buspirone hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
72789-142	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-142	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-142	Buspirone Hydrochloride	buspirone hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current