Home Applications 217513 Application 217513
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE SOLUTION;ORAL EQ 0.05MG BASE/ML Yes Yes 002 MEKINIST TRAMETINIB TABLET;ORAL 2MG No No 003 MEKINIST TRAMETINIB SOLUTION;ORAL 4.7MG 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 N217513-001 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 N217513-001 7378423*PED 2027-11-29 Pediatric extension N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 N217513-001 8703781*PED 2031-04-15 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 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 95 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 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 7378423*PED 2027-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8835443*PED 2025-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 7378423*PED 2027-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8703781*PED 2031-04-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8835443*PED 2025-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 7378423*PED 2027-11-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8703781*PED 2031-04-15 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8835443*PED 2025-12-10 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 7378423*PED 2027-11-29 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8703781*PED 2031-04-15 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8835443*PED 2025-12-10 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 7378423*PED 2027-11-29 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8703781*PED 2031-04-15 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8835443*PED 2025-12-10 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 7378423*PED 2027-11-29 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8703781*PED 2031-04-15 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8835443*PED 2025-12-10 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 7378423*PED 2027-11-29 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8703781*PED 2031-04-15 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 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 Mekinist TRAMETINIB Novartis Pharmaceuticals Corporation 0002ad27-779d-42ab-83b5-bc65453412a1 2026-05-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 217513 application number: NDA217513