Home Applications 218016 Application 218016
Type ANDA
Sponsor HIKMA PHARMS Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218016-001 SOLRIAMFETOL HYDROCHLORIDE SOLRIAMFETOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-06-17 A218016-002 SOLRIAMFETOL HYDROCHLORIDE SOLRIAMFETOL HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2026-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218016-001 SOLRIAMFETOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-06-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218016-002 SOLRIAMFETOL HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2026-06-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218016-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218016-002 AB 1 a50c72e98297…