Application 217513

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEKINISTTRAMETINIB DIMETHYL SULFOXIDESOLUTION;ORALEQ 0.05MG BASE/MLYesYes
002MEKINISTTRAMETINIBTABLET;ORAL2MGNoNo
003MEKINISTTRAMETINIBSOLUTION;ORAL4.7MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217513-001MEKINISTTRAMETINIB DIMETHYL SULFOXIDEEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217513-00173784232027-05-29Drug substance, Drug product2023-05-04
N217513-0017378423*PED2027-11-29Pediatric extension
N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-04
N217513-0018703781*PED2031-04-15Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217513-001NP2026-03-16
N217513-001PED2026-09-16
N217513-001ODE-4282030-03-16
N217513-001PED2030-09-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16c2088c7a36db…
2026-09-14 22:38:342026-08N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-1684e616aacf4f…
2026-08-18 06:07:402026-07N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217513-001MEKINISTEQ 0.05MG BASE/MLSOLUTION / ORALRLD, RS2023-03-16a50c72e98297…

Observed Orange Book patent history#

Patent history page 2 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-00188354432025-06-10U-35642023-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-0018835443*PED2025-12-10Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-00173784232027-05-29Drug substance, Drug product2023-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-0017378423*PED2027-11-29Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-0018703781*PED2031-04-15Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-00188354432025-06-10U-35642023-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-0018835443*PED2025-12-10Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-00173784232027-05-29Drug substance, Drug product2023-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-0017378423*PED2027-11-29Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-0018703781*PED2031-04-15Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-00188354432025-06-10U-35642023-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-0018835443*PED2025-12-10Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-00173784232027-05-29Drug substance, Drug product2023-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-0017378423*PED2027-11-29Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217513-0018703781*PED2031-04-15Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-00188354432025-06-10U-35642023-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-0018835443*PED2025-12-10Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-00173784232027-05-29Drug substance, Drug product2023-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-0017378423*PED2027-11-29Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217513-0018703781*PED2031-04-15Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217513-00188354432025-06-10U-35642023-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N217513-0018835443*PED2025-12-10Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N217513-00173784232027-05-29Drug substance, Drug product2023-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N217513-0017378423*PED2027-11-29Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N217513-0018703781*PED2031-04-15Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217513-00188354432025-06-10U-35642023-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217513-00173784232027-05-29Drug substance, Drug product2023-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217513-00188354432025-06-10U-35642023-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217513-00173784232027-05-29Drug substance, Drug product2023-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217513-00188354432025-06-10U-35642023-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217513-00173784232027-05-29Drug substance, Drug product2023-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217513-00187037812030-10-15U-3564Drug substance, Drug product2023-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217513-00188354432025-06-10U-35642023-05-048072bd15b7f6…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N217513-001NP2026-03-16c2088c7a36db…
2026-10-15 13:18:302026-09N217513-001PED2026-09-16c2088c7a36db…
2026-10-15 13:18:302026-09N217513-001ODE-4282030-03-16c2088c7a36db…
2026-10-15 13:18:302026-09N217513-001PED2030-09-16c2088c7a36db…
2026-09-14 22:38:342026-08N217513-001NP2026-03-1684e616aacf4f…
2026-09-14 22:38:342026-08N217513-001PED2026-09-1684e616aacf4f…
2026-09-14 22:38:342026-08N217513-001ODE-4282030-03-1684e616aacf4f…
2026-09-14 22:38:342026-08N217513-001PED2030-09-1684e616aacf4f…
2026-08-18 06:07:402026-07N217513-001NP2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N217513-001PED2026-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07N217513-001ODE-4282030-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N217513-001PED2030-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217513-001NP2026-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217513-001PED2026-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217513-001ODE-4282030-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217513-001PED2030-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217513-001NP2026-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217513-001PED2026-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217513-001ODE-4282030-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217513-001PED2030-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217513-001NP2026-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217513-001PED2026-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217513-001ODE-4282030-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217513-001PED2030-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217513-001NP2026-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217513-001PED2026-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217513-001ODE-4282030-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217513-001PED2030-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217513-001NP2026-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217513-001PED2026-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217513-001ODE-4282030-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217513-001PED2030-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-001NP2026-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-001PED2026-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-001ODE-4282030-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217513-001PED2030-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-001NP2026-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-001PED2026-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-001ODE-4282030-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217513-001PED2030-09-162680178bc6a6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MekinistTRAMETINIBNovartis Pharmaceuticals Corporation0002ad27-779d-42ab-83b5-bc65453412a12026-05-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 217513
application number: NDA217513

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85625SUPPL 2026-04-02
85592SUPPL 2026-03-30
81911SUPPL 2025-04-09
81837SUPPL 2025-04-08
81667SUPPL 2025-03-21
81525SUPPL 2025-03-21
81658SUPPL 2025-03-20
81657SUPPL 2025-03-20
81513SUPPL 2025-03-11
81257SUPPL 2025-02-14
79970SUPPL 2024-10-24
79811SUPPL 2024-10-03
79100SUPPL 2024-07-15
79058SUPPL 2024-07-12
78036SUPPL 2024-04-03
78025SUPPL 2024-04-01
77647SUPPL 2024-02-28
77637SUPPL 2024-02-28
74265ORIG 2023-05-16
73797ORIG 2023-03-17
73795ORIG 2023-03-17