Home Applications 201292 Application 201292
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GILOTRIF AFATINIB DIMALEATE TABLET;ORAL EQ 20MG BASE Yes No 002 GILOTRIF AFATINIB DIMALEATE TABLET;ORAL EQ 30MG BASE Yes No 003 GILOTRIF AFATINIB DIMALEATE TABLET;ORAL EQ 40MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N201292-001 GILOTRIF AFATINIB DIMALEATE EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 N201292-002 GILOTRIF AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 N201292-003 GILOTRIF AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12
Orange Book patents# Current patent rows page 1 of 1 · 30 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 2026-08-01 22:54:32 2026-06 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 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 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 RE43431*PED 2026-07-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 9539258*PED 2027-05-09 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 8426586*PED 2030-04-10 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 8545884*PED 2030-06-19 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-001 10004743*PED 2031-01-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 RE43431 2026-01-13 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 RE43431*PED 2026-07-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 9539258 2026-11-09 U-1950 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 9539258*PED 2027-05-09 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 8426586 2029-10-10 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 8545884 2029-12-19 Drug product 2013-10-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 8426586*PED 2030-04-10 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 8545884*PED 2030-06-19 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 10004743 2030-07-05 Drug product 2018-08-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-002 10004743*PED 2031-01-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 RE43431 2026-01-13 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 RE43431*PED 2026-07-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 9539258 2026-11-09 U-1950 2017-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 9539258*PED 2027-05-09 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 8426586 2029-10-10 Drug substance 2013-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 8545884 2029-12-19 Drug product 2013-10-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 8426586*PED 2030-04-10 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 8545884*PED 2030-06-19 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 10004743 2030-07-05 Drug product 2018-08-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N201292-003 10004743*PED 2031-01-05 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0137 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0137 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0137 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0137 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0138 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0138 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0138 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0138 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0141 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0141 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0141 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0141 Gilotrif afatinib Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current