Application 202087

Type: ANDA
Sponsor: YILING PHARM LTD

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
004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	7.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A202087-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16
A202087-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16
A202087-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16
A202087-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16
A202087-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202087-001	AB
A202087-002	AB
A202087-003	AB
A202087-004	AB
A202087-005	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 5 · 168 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
2026-02-19 14:30 UTC	2026-02	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202087-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202087-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202087-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202087-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202087-001	AB	1	`d06236e962d9…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	55810b17-4796-49d0-90e4-8e075d62eda4	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	427ad27e-6664-afee-e063-6394a90a1890	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	45c637b7-3057-ea38-e063-6394a90a87b6	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	424d81f0-b195-5bc2-e063-6394a90a2104	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	3f66a3fe-9d73-180c-e063-6394a90aacca	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	EPIC PHARMA, LLC	e8f43c66-f8de-419f-9ea9-43ddc4ec0798	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087 ndc (product): 42806-663 ndc (product): 42806-665 ndc (product): 42806-664 ndc (product): 42806-662

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-662	Buspirone hydrochloride	Buspirone hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-663	Buspirone hydrochloride	Buspirone hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-664	Buspirone hydrochloride	Buspirone hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-665	Buspirone hydrochloride	Buspirone hydrochloride	EPIC PHARMA, LLC	ANDA	Current
69117-0040	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0040	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0040	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0040	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0041	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0041	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0041	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0041	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0042	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0042	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0042	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0042	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0043	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0043	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0043	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0043	Buspirone hydrochloride	Buspirone hydrochloride	Yiling Pharmaceutical, Inc.	ANDA	Current
70934-859	Buspirone hydrochloride	Buspirone hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current