Home Applications 077543 Application 077543
Type ANDA
Sponsor CHARTWELL MOLECULAR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RISPERIDONE RISPERIDONE TABLET;ORAL 0.25MG No No 002 RISPERIDONE RISPERIDONE TABLET;ORAL 0.5MG No No 003 RISPERIDONE RISPERIDONE TABLET;ORAL 1MG No No 004 RISPERIDONE RISPERIDONE TABLET;ORAL 2MG No No 005 RISPERIDONE RISPERIDONE TABLET;ORAL 3MG No No 006 RISPERIDONE RISPERIDONE TABLET;ORAL 4MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077543-001 RISPERIDONE RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 A077543-002 RISPERIDONE RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 A077543-003 RISPERIDONE RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 A077543-004 RISPERIDONE RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 A077543-005 RISPERIDONE RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 A077543-006 RISPERIDONE RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-005 RISPERIDONE 3MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077543-006 RISPERIDONE 4MG TABLET / ORAL AB 2011-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077543-001 RISPERIDONE 0.25MG TABLET / ORAL AB 2011-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077543-002 RISPERIDONE 0.5MG TABLET / ORAL AB 2011-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077543-003 RISPERIDONE 1MG TABLET / ORAL AB 2011-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077543-004 RISPERIDONE 2MG TABLET / ORAL AB 2011-05-18 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 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 Chartwell RX, LLC 12a479c4-a84a-4308-b89f-be0315826fd5 2024-04-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077543 application number: ANDA077543