Home Applications 075413 Application 075413
Type ANDA
Sponsor FOSUN PHARMA 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 RLD / RS Approval date A075413-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-19 A075413-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-19 A075413-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-19 A075413-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2025-10-06 A075413-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 139 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 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075413-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075413-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075413-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075413-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075413-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075413-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075413-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075413-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075413-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2002-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075413-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2002-03-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075413-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2002-03-19 d8e5a09893c0…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 8659 ORIG 2003-04-10