Application 208972

Type: ANDA
Sponsor: EPIC PHARMA LLC

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
006	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
007	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208972-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16
A208972-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16
A208972-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16
A208972-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16
A208972-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16
A208972-006	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13
A208972-007	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208972-001	AB
A208972-002	AB
A208972-003	AB
A208972-004	AB
A208972-005	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 6 · 214 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	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-006	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-007	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A208972-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208972-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-004	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-005	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-004	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-005	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208972-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-004	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-005	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208972-005	AB	1	`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	IPG Pharmaceuticals, Inc	2c516eec-65d9-4481-8823-ae6b6da84062	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27db85e9-68ef-4d43-a319-4e2ec8dbae05	2020-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972 ndc (product): 71610-404
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Epic Pharma, LLC	02628a0c-bfdb-4a58-8e48-bcd8ca12d53b	2019-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972 ndc (product): 42806-082 ndc (product): 42806-085 ndc (product): 42806-086 ndc (product): 42806-083 ndc (product): 42806-084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-082	Buspirone Hydrochloride	Buspirone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-083	Buspirone Hydrochloride	Buspirone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-084	Buspirone Hydrochloride	Buspirone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-085	Buspirone Hydrochloride	Buspirone Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-086	Buspirone Hydrochloride	Buspirone Hydrochloride	Epic Pharma, LLC	ANDA	Current
55700-881	Buspirone Hydrochloride	Buspirone Hydrochloride	Quality Care Products, LLC	ANDA	Current
70518-2830	Buspirone Hydrochloride	Buspirone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2830	Buspirone Hydrochloride	Buspirone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3607	Buspirone Hydrochloride	Buspirone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71610-404	Buspirone Hydrochloride	Buspirone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current