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 43.

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075467-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	2002-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075467-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2001-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075467-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	2002-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075467-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	2002-02-28	`caaa826d4ba7…`
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…`

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 5 of 9 · 164 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b217f341-7d51-475d-887f-f16786164c7b	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	270398a0-21b8-407b-af76-4aeef90f72be	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	3f66a3fe-9d73-180c-e063-6394a90aacca	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	48b4e52d-d4c4-4d24-a0ac-24316371cef0	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dd7f213-afd8-67d6-e063-6294a90ac108	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	65c69118-36bb-4f0d-9669-b52556056ec5	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ed7e334a-cc4a-47b2-a4db-56495730b698	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	5d93a30e-3544-44e7-ab6a-dc9dc79d7c71	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Strides Pharma Science Limited	cff9f09a-1ea2-4968-b57b-e62bebaae238	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1790d63d-ecb1-da9d-e063-6294a90a50ba	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b41fd76-c3cc-77f0-e063-6294a90aa778	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Institutional Inc.	91bb5fc9-5121-43c2-b2af-149240d4189a	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	335107c9-5799-c4df-e063-6294a90a5ca0	2025-04-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	08efb26e-488c-49d4-8432-98db855962e9	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	897dac69-a59b-423c-be16-6301c7e504d9	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b6352207-e708-44a7-8a63-93b96613e1e7	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	EPIC PHARMA, LLC	160f52d2-2e08-4969-80c3-c653767652f0	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30c93022-4126-db8c-e063-6394a90a7579	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE

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 · 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