Home Applications 075385 Application 075385
Type ANDA
Sponsor IVAX SUB TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075385-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 A075385-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 A075385-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01
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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 A075385-001 BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075385-002 BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075385-003 BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075385-001 BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075385-002 BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075385-003 BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075385-001 BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075385-002 BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075385-003 BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075385-001 BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075385-002 BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075385-003 BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2002-03-01 a50c72e98297…
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 · 163 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 2026-09-04 Warnings, Adverse reactions Name fallback brand name: BUSPIRONE HYDROCHLORIDE generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Cardinal Health 107, LLC ef90af23-d97e-4094-971b-1d8114218b10 2026-09-02 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE REMEDYREPACK INC. ed2b56fe-e02f-46bc-808a-352f9bbb5b57 2026-08-27 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Major Pharmaceuticals 8dc1ee33-e5aa-4462-8fb9-9bbdf5463488 2026-08-05 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE Proficient Rx LP 801803eb-be17-4064-8813-7ccf52316cde 2026-08-01 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE Buspirone Hydrochloride BUSPIRONE HYDROCHLORIDE REMEDYREPACK INC. 3155e607-bc7f-4e90-9edf-8e862dd5737d 2026-07-31 Warnings, Adverse reactions Name fallback brand name: Buspirone Hydrochloride generic name: BUSPIRONE HYDROCHLORIDE 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 Cardinal Health 107, LLC 2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd 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 Golden State Medical Supply, Inc. bcce49d3-c8eb-9f9b-e053-2995a90a67d9 2026-07-27 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 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 Northwind Health Company, LLC 1d883a13-4877-c6c7-e063-6294a90a5137 2026-06-19 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-4575 Buspirone Hydrochloride Buspirone Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4595 Buspirone Hydrochloride Buspirone Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4596 Buspirone Hydrochloride Buspirone Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8641 ORIG 2004-05-28 30868 ORIG 2003-04-10