Home Applications 212091 Application 212091
Type ANDA
Sponsor PIRAMAL HLTHCARE UK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 20MG No No 002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 40MG No No 003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 60MG No No 004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 80MG No No 005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE TABLET;ORAL 120MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A212091-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 A212091-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 A212091-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 A212091-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 A212091-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28
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 5 · 180 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 2026-08-18 06:07:40 2026-07 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212091-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2020-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212091-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2020-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212091-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2020-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212091-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2020-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212091-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2020-12-28 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 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.
Documents# Document, Submission type, Date table Document Submission type Date 63102 ORIG 2020-05-19