Home Applications 074253 Application 074253
Type ANDA
Sponsor IMPAX LABS INC 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074253-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 A074253-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 A074253-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 4 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 Zydus Lifesciences Limited 1109dd63-6492-49b1-a383-3ab3a80cd6c7 2025-12-24 Name fallback brand name: buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone hydrochloride BUSPIRONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 45c637b7-3057-ea38-e063-6394a90a87b6 2025-12-12 Warnings, Adverse reactions Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone hydrochloride BUSPIRONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 424d81f0-b195-5bc2-e063-6394a90a2104 2025-12-10 Warnings, Adverse reactions Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE A-S Medication Solutions 338f3317-96c0-4b8a-8299-8ce2a10911ae 2025-12-02 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE A-S Medication Solutions e4d44e49-eb8f-454e-a737-22caf30bda78 2025-12-01 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Boswell Pharmacy Services LLC d/b/a BPS Wholesale 438f5c4d-a009-b851-e063-6394a90a084a 2025-11-13 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f 2025-11-10 Warnings, Adverse reactions Name fallback brand name: Buspirone hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 4ff72575-bd60-40ce-b3a8-fd92b79af674 2025-11-07 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack 49659ee7-ca08-4df1-8e6b-3a366a7839c7 2025-11-04 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack eb072818-3ca8-430b-91a1-e7fedd37990c 2025-11-04 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack aba814f0-55ce-4480-99f1-b9ad1ba77d3f 2025-11-03 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack bee0edbf-3fc3-484b-9715-f13a329216ae 2025-11-03 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE A-S Medication Solutions 38677cd0-2ee6-4c8f-8553-36310b2813a1 2025-11-02 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack 4e7640d1-0a31-4f97-82bb-574cf1ff6e4a 2025-10-28 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 40d5813d-d040-002c-e063-6294a90a5f7a 2025-10-10 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE A-S Medication Solutions 7c7225a0-8237-4998-843a-bf10fa6ec65b 2025-10-09 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Accord Healthcare Inc. 3da22999-f5fb-49fd-acde-c3006598e985 2025-10-07 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack 2df0b238-14a4-40ca-a235-411f6c9b8338 2025-10-06 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack 790b6159-c03b-4a3a-be6b-add35a3114a4 2025-10-03 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Bryant Ranch Prepack f85b59b7-b945-4440-8378-987bd287a655 2025-10-01 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 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0115-1690 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0115-1690 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0115-1691 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0115-1691 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0115-1692 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0115-1692 Buspirone HCl Buspirone hydrochloride Impax Generics ANDA Current 0591-0658 Buspirone HCl Buspirone hydrochloride Actavis Pharma, Inc. ANDA Current 0591-0718 Buspirone HCl Buspirone hydrochloride Actavis Pharma, Inc. ANDA Current 10544-176 Buspirone HCl Buspirone hydrochloride Blenheim Pharmacal, Inc. ANDA Current 21695-172 Buspirone HCl Buspirone hydrochloride Rebel Distributors Corp. ANDA Current 21695-217 Buspirone HCl Buspirone hydrochloride Rebel Distributors Corp. ANDA Current 21695-256 Buspirone HCl Buspirone hydrochloride Rebel Distributors Corp. ANDA Current 49999-812 Buspirone Hydrochloride Buspirone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 50090-1485 Buspirone HCl Buspirone hydrochloride A-S Medication Solutions ANDA Current 50090-1691 Buspirone HCl Buspirone hydrochloride A-S Medication Solutions ANDA Current 53808-0856 Buspirone HCl Buspirone hydrochloride State of Florida DOH Central Pharmacy ANDA Current 53808-0907 Buspirone HCl Buspirone hydrochloride State of Florida DOH Central Pharmacy ANDA Current 55700-001 Buspirone HCl Buspirone hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 58517-340 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE New Horizon Rx Group, LLC ANDA Current 63187-221 Buspirone HCl Buspirone hydrochloride Proficient Rx LP ANDA Current 63187-221 Buspirone HCl Buspirone hydrochloride Proficient Rx LP ANDA Current 63187-645 Buspirone HCl Buspirone hydrochloride Proficient Rx LP ANDA Current 63187-645 Buspirone HCl Buspirone hydrochloride Proficient Rx LP ANDA Current 63629-3047 Buspirone HCl Buspirone hydrochloride Bryant Ranch Prepack ANDA Current 63629-3197 Buspirone HCl Buspirone hydrochloride Bryant Ranch Prepack ANDA Current 63629-6366 Buspirone HCl Buspirone hydrochloride Bryant Ranch Prepack ANDA Current 64725-0657 Buspirone HCl Buspirone hydrochloride TYA Pharmaceuticals ANDA Current 64725-0658 Buspirone HCl Buspirone hydrochloride TYA Pharmaceuticals ANDA Current 66336-052 Buspirone HCl Buspirone hydrochloride Dispensing Solutions, Inc. ANDA Current 67296-1081 Buspirone HCl Buspirone HCl RedPharm Drug, Inc. ANDA Current 67296-1081 Buspirone HCl Buspirone HCl RedPharm Drug, Inc. ANDA Current 68258-7087 Buspirone HCl Buspirone hydrochloride Dispensing Solutions, Inc. ANDA Current 68788-0053 Buspirone HCl Buspirone hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30673 SUPPL 2003-04-09 8410 SUPPL 2003-04-09 30672 ORIG 2001-03-28