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 43 .
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 AB RLD 2013-07-12 N201292-002 GILOTRIF AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 N201292-003 GILOTRIF AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 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 2026-09-14 22:38:34 2026-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL AB RLD 2013-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL AB RLD 2013-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 29 · 1,140 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 RE43431*PED 2026-07-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 9539258*PED 2027-05-09 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8426586*PED 2030-04-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8545884*PED 2030-06-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 10004743*PED 2031-01-05 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 523 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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