Home Applications 218586 Application 218586
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 12.5MG/VIAL No No 002 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 25MG/VIAL No No 003 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 37.5MG/VIAL No No 004 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 50MG/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 TE codes RLD / RS Approval date A218586-001 RISPERIDONE RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-002 RISPERIDONE RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-003 RISPERIDONE RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A218586-004 RISPERIDONE RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
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 2026-08-18 06:07:40 2026-07 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218586-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218586-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Risperidone RISPERIDONE Amneal Pharmaceuticals LLC d526af85-ee70-4657-a27e-d451027ffd9e 2026-07-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218586 application number: ANDA218586