Home Applications 211654 Application 211654
Type ANDA
Sponsor MSN LABS PVT LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TASIMELTEON TASIMELTEON CAPSULE; ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211654-001 TASIMELTEON TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211654-001 AB
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 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 74047 ORIG 2023-04-24 63460 ORIG 2020-06-09