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.
Product history page 1 of 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,080 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 RE43431*PED 2026-07-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 9539258*PED 2027-05-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 8426586*PED 2030-04-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 8545884*PED 2030-06-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-001 10004743*PED 2031-01-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 RE43431 2026-01-13 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 RE43431*PED 2026-07-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 9539258 2026-11-09 U-1950 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 9539258*PED 2027-05-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 8426586 2029-10-10 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 8545884 2029-12-19 Drug product 2013-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 8426586*PED 2030-04-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 8545884*PED 2030-06-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 10004743 2030-07-05 Drug product 2018-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 10004743*PED 2031-01-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 RE43431 2026-01-13 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 RE43431*PED 2026-07-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 9539258 2026-11-09 U-1950 2017-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 9539258*PED 2027-05-09 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 8426586 2029-10-10 Drug substance 2013-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 8545884 2029-12-19 Drug product 2013-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 8426586*PED 2030-04-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 8545884*PED 2030-06-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 10004743 2030-07-05 Drug product 2018-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 10004743*PED 2031-01-05 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 RE43431*PED 2026-07-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 9539258*PED 2027-05-09 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 8426586*PED 2030-04-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 8545884*PED 2030-06-19 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 10004743*PED 2031-01-05 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 523 observed states.
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