Application 209696

Type: ANDA
Sponsor: INVENTIA HLTHCARE

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 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
A209696-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03
A209696-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03
A209696-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03
A209696-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03
A209696-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209696-001	BX
A209696-002	BX
A209696-003	BX
A209696-004	BX
A209696-005	BX

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 · 205 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	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A209696-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	AB	1	`5bbf6a4d5a75…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	267d8897-90dd-4f8a-bbd8-8aa4e47c2905	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696 ndc (product): 71335-1144
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	APNAR PHARMA LP	3c115eea-9dbc-4e2c-9d79-42e3388fde5a	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696 ndc (product): 24689-785 ndc (product): 24689-921 ndc (product): 24689-933 ndc (product): 24689-907 ndc (product): 24689-781
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Nivagen Pharmaceuticals Inc.	b08dd2e7-e808-4b51-b404-5009076b82eb	2021-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696 ndc (product): 75834-269 ndc (product): 75834-268 ndc (product): 75834-267 ndc (product): 75834-266 ndc (product): 75834-270
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	03efd618-8ca3-43d0-bbeb-55e53b5308e8	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696 ndc (product): 71205-280
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e2c672b3-6130-4dd1-8066-0ce9451cb8c7	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696 ndc (product): 71610-291

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24689-781	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-781	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-785	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-785	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-907	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-907	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-921	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-921	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-933	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
24689-933	BusPIRone Hydrochloride	BusPIRone Hydrochloride	APNAR PHARMA LP	ANDA	Current
49252-098	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Inventia Healthcare Private Limited	ANDA	Current
49252-099	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Inventia Healthcare Private Limited	ANDA	Current
49252-100	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Inventia Healthcare Private Limited	ANDA	Current
49252-101	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Inventia Healthcare Private Limited	ANDA	Current
49252-107	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Inventia Healthcare Private Limited	ANDA	Current
53002-5017	BusPIRone Hydrochloride	BusPIRone Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
71205-280	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Proficient Rx LP	ANDA	Current
71205-280	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1144	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1144	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-281	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-291	BusPIRone Hydrochloride	BusPIRone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
75834-266	Buspirone Hydrochloride	Buspirone Hydrochloride	Nivagen Pharmaceuticals Inc.	ANDA	Current
75834-267	Buspirone Hydrochloride	Buspirone Hydrochloride	Nivagen Pharmaceuticals Inc.	ANDA	Current
75834-268	Buspirone Hydrochloride	Buspirone Hydrochloride	Nivagen Pharmaceuticals Inc.	ANDA	Current
75834-269	Buspirone Hydrochloride	Buspirone Hydrochloride	Nivagen Pharmaceuticals Inc.	ANDA	Current
75834-270	Buspirone Hydrochloride	Buspirone Hydrochloride	Nivagen Pharmaceuticals Inc.	ANDA	Current