Home Applications 214068 Application 214068
Type ANDA
Sponsor TEVA PHARMS USA INC 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 43 .
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 A214068-001 RISPERIDONE RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 A214068-002 RISPERIDONE RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 A214068-003 RISPERIDONE RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 A214068-004 RISPERIDONE RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05
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.
Product history page 1 of 2 · 76 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 A214068-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214068-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214068-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214068-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214068-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214068-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214068-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214068-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214068-001 RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214068-002 RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214068-003 RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214068-004 RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB 2023-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214068-001 RISPERIDONE 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214068-002 RISPERIDONE 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214068-003 RISPERIDONE 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214068-004 RISPERIDONE 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB 2023-12-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Risperidone RISPERIDONE Teva Pharmaceuticals, Inc. 32c0f081-b418-4c1c-b39e-eb5c344043c7 2025-02-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214068 application number: ANDA214068
Documents# Document, Submission type, Date table Document Submission type Date 84210 ORIG 2025-11-19