Home Applications 218495 Application 218495
Type ANDA
Sponsor NOVITIUM PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 PITOLISANT PITOLISANT TABLET 17.8MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218495-001 PITOLISANT HYDROCHLORIDE PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE TABLET / ORAL AB 2026-07-21 A218495-002 PITOLISANT HYDROCHLORIDE PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE TABLET / ORAL AB 2026-07-21
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 2026-09-14 22:38:34 2026-08 A218495-001 PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE TABLET / ORAL AB 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218495-002 PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE TABLET / ORAL AB 2026-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218495-001 PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE TABLET / ORAL AB 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218495-002 PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE TABLET / ORAL AB 2026-07-21 caaa826d4ba7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.