Home Applications 216843 Application 216843
Type ANDA
Sponsor PAR PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALVIMOPAN ALVIMOPAN CAPSULE;ORAL 12MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A216843-001 ALVIMOPAN ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216843-001 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 2026-02-19 14:30 UTC 2026-02 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216843-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-01-24 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALVIMOPAN ALVIMOPAN Par Health USA, LLC 1cd584de-b704-4d26-8451-e3247ffb8d08 2024-02-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216843 application number: ANDA216843
Documents# Document, Submission type, Date table Document Submission type Date 83467 SUPPL 2025-09-25 76421 ORIG 2023-11-06