Application 074253

Type: ANDA
Sponsor: IMPAX LABS INC

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
A074253-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28
A074253-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28
A074253-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074253-001	AB
A074253-002	AB
A074253-003	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	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A074253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074253-001	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 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 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1690	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0115-1690	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0115-1691	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0115-1691	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0115-1692	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0115-1692	Buspirone HCl	Buspirone hydrochloride	Impax Generics	ANDA	Current
0591-0658	Buspirone HCl	Buspirone hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-0718	Buspirone HCl	Buspirone hydrochloride	Actavis Pharma, Inc.	ANDA	Current
10544-176	Buspirone HCl	Buspirone hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
21695-172	Buspirone HCl	Buspirone hydrochloride	Rebel Distributors Corp.	ANDA	Current
21695-217	Buspirone HCl	Buspirone hydrochloride	Rebel Distributors Corp.	ANDA	Current
21695-256	Buspirone HCl	Buspirone hydrochloride	Rebel Distributors Corp.	ANDA	Current
49999-812	Buspirone Hydrochloride	Buspirone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1485	Buspirone HCl	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1691	Buspirone HCl	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0856	Buspirone HCl	Buspirone hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0907	Buspirone HCl	Buspirone hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
55700-001	Buspirone HCl	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58517-340	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	New Horizon Rx Group, LLC	ANDA	Current
63187-221	Buspirone HCl	Buspirone hydrochloride	Proficient Rx LP	ANDA	Current
63187-221	Buspirone HCl	Buspirone hydrochloride	Proficient Rx LP	ANDA	Current
63187-645	Buspirone HCl	Buspirone hydrochloride	Proficient Rx LP	ANDA	Current
63187-645	Buspirone HCl	Buspirone hydrochloride	Proficient Rx LP	ANDA	Current
63629-3047	Buspirone HCl	Buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3197	Buspirone HCl	Buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6366	Buspirone HCl	Buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
64725-0657	Buspirone HCl	Buspirone hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-0658	Buspirone HCl	Buspirone hydrochloride	TYA Pharmaceuticals	ANDA	Current
66336-052	Buspirone HCl	Buspirone hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
67296-1081	Buspirone HCl	Buspirone HCl	RedPharm Drug, Inc.	ANDA	Current
67296-1081	Buspirone HCl	Buspirone HCl	RedPharm Drug, Inc.	ANDA	Current
68258-7087	Buspirone HCl	Buspirone hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
68788-0053	Buspirone HCl	Buspirone hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30673	SUPPL	2003-04-09
8410	SUPPL	2003-04-09
30672	ORIG	2001-03-28