Home Applications 217514 Application 217514
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAFINLAR DABRAFENIB MESYLATE TABLET, FOR SUSPENSION;ORAL EQ 10MG BASE Yes Yes 002 TAFINLAR DABRAFENIB MESYLATE CAPSULE;ORAL 75MG No No 003 TAFINLAR DABRAFENIB MESYLATE TABLET; ORAL SUSPENSION 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217514-001 TAFINLAR DABRAFENIB MESYLATE EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 N217514-001 7994185*PED 2030-07-20 Pediatric extension N217514-001 8415345*PED 2030-07-20 Pediatric extension N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 N217514-001 8703781*PED 2031-04-15 Pediatric extension N217514-001 11504333 2038-06-29 Drug product 2023-05-04 N217514-001 11504333*PED 2038-12-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 2026-02-19 14:30 UTC 2026-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 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 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 7994185*PED 2030-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8415345*PED 2030-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 11504333*PED 2038-12-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8835443*PED 2025-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 7994185*PED 2030-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8415345*PED 2030-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8703781*PED 2031-04-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 11504333*PED 2038-12-29 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8835443*PED 2025-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 7994185*PED 2030-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8415345*PED 2030-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8703781*PED 2031-04-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 11504333*PED 2038-12-29 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8835443*PED 2025-12-10 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 7994185*PED 2030-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8415345*PED 2030-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8703781*PED 2031-04-15 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 11504333*PED 2038-12-29 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 8835443*PED 2025-12-10 Pediatric extension b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tafinlar DABRAFENIB Novartis Pharmaceuticals Corporation fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea 2026-05-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 217514 application number: NDA217514