Home Applications 022527 Application 022527
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GILENYA FINGOLIMOD HYDROCHLORIDE CAPSULE;ORAL EQ 0.5MG BASE Yes Yes 002 GILENYA FINGOLIMOD HYDROCHLORIDE CAPSULE;ORAL EQ 0.25MG BASE Yes No
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 N022527-001 GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB RLD, RS 2010-09-21 N022527-002 GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022527-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022527-001 10543179 2027-12-25 U-2719 2020-01-28 N022527-002 9592208 2032-03-30 U-2315 Drug product 2018-06-19 N022527-002 9592208*PED 2032-09-30 Pediatric extension
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 2026-08-01 22:54:32 2026-06 N022527-001 GILENYA EQ 0.5MG BASE CAPSULE / ORAL AB RLD, RS 2010-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 GILENYA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022527-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022527-001 10543179 2027-12-25 U-2719 2020-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 9592208 2032-03-30 U-2315 Drug product 2018-06-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 9592208*PED 2032-09-30 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0607 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current 0078-0965 Gilenya Fingolimod hcl Novartis Pharmaceuticals Corporation NDA Current