Home Applications 211220 Application 211220
Type ANDA
Sponsor NANOMI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 25MG/VIAL No No 002 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 37.5MG/VIAL No No 003 RISPERIDONE RISPERIDONE POWDER;INTRAMUSCULAR 50MG/VIAL 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 A211220-001 RISPERIDONE RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A211220-002 RISPERIDONE RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 A211220-003 RISPERIDONE RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A211220-001 CGT 2026-05-12 A211220-002 CGT 2026-05-09 A211220-003 CGT 2026-05-09
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 2026-09-14 22:38:34 2026-08 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-001 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-002 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211220-003 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2025-09-02 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-001 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-002 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211220-003 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2025-09-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 Lupin Pharmaceuticals, Inc. b462e48c-ef1d-4591-8fca-6b5829d8ed90 2026-02-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211220 application number: ANDA211220
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.