Application 075467

Type: ANDA
Sponsor: MYLAN

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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075467-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28
A075467-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28
A075467-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28
A075467-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075467-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075467-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075467-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075467-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075467-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075467-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075467-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075467-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075467-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075467-002	AB	1	`ea99ee380514…`

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 9 · 165 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	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fd05160d-24c6-4371-8b2c-c0f78c8b468e	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Redpharm Drug	5718bc19-07b2-b61d-e063-6394a90a6e80	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	a9fc7091-b3ce-45fd-8d89-aeebdd81c327	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Bucapsol	BUSPIRONE HYDROCHLORIDE	PANGEA PHARMACEUTICALS, LLC	f101c5f3-d533-474d-a8bf-90d054933d16	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Strides Pharma Inc.	cb0091ad-97f6-431b-b2b9-e03171eed274	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	b42cc365-6259-4d2e-9648-d37718b65e1e	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	a9bb9216-3dac-4e8a-9df9-f72c2eaef160	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	IPG Pharmaceuticals, Inc	2c516eec-65d9-4481-8823-ae6b6da84062	2026-06-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
busPIRone HCl	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	472049d2-c4d9-5a38-e063-6294a90a5cf1	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544a4570-bd7f-72bb-e063-6394a90ab8d6	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544b8918-7175-655f-e063-6394a90a453a	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fbff8248-b73c-474e-907e-449f8316c629	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	53e7576a-e2f4-042b-e063-6294a90ae035	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	66df7f74-5dea-46d6-9ef8-9bab37baf407	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	225575f1-9635-4922-8286-d479d6480bf0	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-5548	BusPIRone Hydrochloride	Buspirone Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-176	Buspirone Hydrochloride	buspirone hydrochloride	AvKARE, Inc.	ANDA	Current
42291-176	Buspirone Hydrochloride	buspirone hydrochloride	AvKARE	ANDA	Current
49884-725	Buspirone Hydrochloride	buspirone hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-725	Buspirone Hydrochloride	buspirone hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-725	Buspirone Hydrochloride	buspirone hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-725	Buspirone Hydrochloride	buspirone hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
63629-6817	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6817	Buspirone Hydrochloride	buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-2303	Buspirone Hydrochloride	buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2303	Buspirone Hydrochloride	buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2303	Buspirone Hydrochloride	buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30896	SUPPL	2003-04-10
8681	SUPPL	2003-04-10
22474	ORIG	2002-07-17
30895	ORIG	2001-03-28