Application 075521

Type: ANDA
Sponsor: RUBICON

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075521-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05
A075521-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05
A075521-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05
A075521-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16
A075521-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075521-001	AB
A075521-002	AB
A075521-003	AB
A075521-004	AB
A075521-005	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
2026-09-14 22:38:34	2026-08	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-004	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2021-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2021-03-16	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 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	A075521-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075521-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075521-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075521-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075521-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075521-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075521-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075521-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075521-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075521-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075521-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075521-005	AB	1	`03ed91905a0d…`

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 HCl	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	472049d2-c4d9-5a38-e063-6294a90a5cf1	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075521 application number: ANDA075521
busPIRone HCl	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	138b84a5-966b-47d7-a3d6-395df83f8aa5	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075521 application number: ANDA075521
busPIRone HCl	BUSPIRONE HYDROCHLORIDE	Advagen Pharma Ltd	07a789a9-c9e8-4737-a56d-7d5405fe8100	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075521 application number: ANDA075521 ndc (product): 72888-063 ndc (product): 72888-062 ndc (product): 72888-066 ndc (product): 72888-065 ndc (product): 72888-064

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3428	busPIRone HCl	buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
72888-062	busPIRone HCl	buspirone hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-063	busPIRone HCl	buspirone hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-064	busPIRone HCl	buspirone hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-065	busPIRone HCl	buspirone hydrochloride	Advagen Pharma Ltd	ANDA	Current
72888-066	busPIRone HCl	buspirone hydrochloride	Advagen Pharma Ltd	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8706	ORIG	2004-05-28
8707	ORIG	2003-04-10