Home Applications 215358 Application 215358
Type NDA
Sponsor NOVARTIS PHARMS CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SCEMBLIX ASCIMINIB TABLET;ORAL 20MG No No 002 SCEMBLIX ASCIMINIB TABLET;ORAL 40MG No No 003 SCEMBLIX ASCIMINIB HYDROCHLORIDE TABLET;ORAL EQ 100MG 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 N215358-001 SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 N215358-002 SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL RLD 2021-10-29 N215358-003 SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL RLD, RS 2024-04-18
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 N215358-003 12252479 2040-05-17 U-1374 2025-04-04
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 19 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 3 · 81 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 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD 2021-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD, RS 2024-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD, RS 2021-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD 2024-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 5 · 172 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 N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215358-001 8829195 2033-05-13 U-1374 Drug substance 2021-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-002 8829195 2033-05-13 U-1374 Drug substance 2021-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-003 8829195 2033-05-13 U-1374 Drug substance 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-001 8829195 2033-05-13 U-1374 Drug substance 2021-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-002 8829195 2033-05-13 U-1374 Drug substance 2021-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 294 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-1091 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current 0078-1091 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current 0078-1091 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current 0078-1098 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current 0078-1098 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current 0078-1098 SCEMBLIX asciminib Novartis Pharmaceuticals Corporation NDA Current