Home Applications 218459 Application 218459
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SIPONIMOD SIPONIMOD TABLET;ORAL EQ 0.25MG BASE No No 002 SIPONIMOD SIPONIMOD TABLET;ORAL EQ 1MG BASE No No 003 SIPONIMOD SIPONIMOD TABLET;ORAL EQ 2MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218459-001 SIPONIMOD SIPONIMOD EQ 0.25MG BASE TABLET / ORAL 2026-03-06 A218459-002 SIPONIMOD SIPONIMOD EQ 1MG BASE TABLET / ORAL 2026-03-06 A218459-003 SIPONIMOD SIPONIMOD EQ 2MG BASE TABLET / ORAL 2026-03-06
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 2026-08-18 06:07:40 2026-07 A218459-001 SIPONIMOD EQ 0.25MG BASE TABLET / ORAL 2026-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218459-002 SIPONIMOD EQ 1MG BASE TABLET / ORAL 2026-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218459-003 SIPONIMOD EQ 2MG BASE TABLET / ORAL 2026-03-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218459-001 SIPONIMOD EQ 0.25MG BASE TABLET / ORAL 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218459-002 SIPONIMOD EQ 1MG BASE TABLET / ORAL 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218459-003 SIPONIMOD EQ 2MG BASE TABLET / ORAL 2026-03-06 a50c72e98297…
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 MAYZENT SIPONIMOD Novartis Pharmaceuticals Corporation 44492772-5aed-4627-bd85-e8e89f308bb3 2026-06-30 Warnings, Adverse reactions Name fallback generic name: SIPONIMOD