Application 208829

Type: ANDA
Sponsor: AMNEAL PHARMS CO

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	7.5MG	No	No
003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A208829-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24
A208829-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24
A208829-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24
A208829-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24
A208829-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24

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 6 · 215 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	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208829-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208829-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2017-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208829-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2017-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208829-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208829-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-05-24	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208829-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208829-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208829-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208829-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208829-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208829-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208829-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208829-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208829-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208829-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208829-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208829-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208829-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208829-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208829-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208829-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208829-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208829-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208829-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208829-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208829-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208829-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208829-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208829-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208829-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208829-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208829-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208829-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208829-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208829-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208829-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208829-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208829-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208829-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208829-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208829-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208829-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208829-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208829-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208829-005	AB	1	`5aa47cf7b7d7…`

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 9 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	Aphena Pharma Solutions - Tennessee, LLC	fac49d42-7bc0-435f-bce2-2548dcdd6de6	2018-12-20	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	310c6bea-838b-43e4-87e0-a0050829c242	2018-12-19	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b7e3a98c-9ec5-4c21-9218-0d53a555a75c	2018-11-08	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78	2018-10-18	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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4657	busPIRone HCl	buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
55700-803	busPIRone HCl	buspirone hydrochloride	Quality Care Products, LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1115	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1116	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1117	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1118	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1119	busPIRone HCl	buspirone hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-1390	busPIRone HCl	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1390	busPIRone HCl	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current