Application 078246

Type: ANDA
Sponsor: AUROBINDO PHARMA 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
A078246-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27
A078246-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27
A078246-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27
A078246-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27
A078246-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078246-001	AB
A078246-002	AB
A078246-003	AB
A078246-004	AB
A078246-005	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 · 201 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	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	A078246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa4d5cac-f687-4440-99d2-8bb27cf2f4ed	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fc0f93c8-2078-b2ff-e053-6294a90aacdf	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	529ab1f9-534c-4a45-aa70-76e605247af1	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	75b1ae3f-e926-4555-a0e9-50323fc66cb2	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	55e32128-711d-4e95-b58b-e86e0afa4983	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 71335-2193
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	d47cde56-e1ab-41fe-832e-d3f33b884a5e	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 71335-2081
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	501b0406-f56e-44d3-906a-7625b936f075	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 50090-6188
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2bc87b32-bdb7-4ce6-8a51-aed623f7219e	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 71335-2073
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	05c006d2-44b9-431f-bce2-aff09c043ecb	2021-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 59651-391 ndc (product): 59651-390 ndc (product): 59651-389 ndc (product): 59651-392 ndc (product): 59651-393

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6188	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
55111-472	Buspirone Hydrochloride	Buspirone Hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-473	Buspirone Hydrochloride	Buspirone Hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-474	Buspirone Hydrochloride	Buspirone Hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-475	Buspirone Hydrochloride	Buspirone Hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
59651-389	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-389	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-390	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-390	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-391	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-391	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-392	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-392	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-393	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
59651-393	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	ANDA	Current
71335-2073	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-2081	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-2193	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current