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 44 .
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 · 90 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 2026-10-15 13:18:30 2026-09 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD 2021-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD, RS 2024-04-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD 2021-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD, RS 2024-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215358-001 SCEMBLIX EQ 20MG BASE TABLET / ORAL RLD 2021-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-002 SCEMBLIX EQ 40MG BASE TABLET / ORAL RLD 2021-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-003 SCEMBLIX EQ 100MG BASE TABLET / ORAL RLD, RS 2024-04-18 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 6 · 208 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215358-001 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-001 11407735 2040-05-14 Drug substance 2022-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-001 12252478 2040-05-14 Drug product 2025-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-001 12252479 2040-05-17 U-1374 2025-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-002 8829195 2035-10-29 U-1374 Drug substance 2021-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-002 11407735 2040-05-14 Drug substance 2022-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-002 12252478 2040-05-14 Drug product 2025-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-002 12252479 2040-05-17 U-1374 2025-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-003 8829195 2035-10-29 U-1374 Drug substance 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-003 11407735 2040-05-14 Drug substance 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-003 12252478 2040-05-14 Drug product 2025-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215358-003 12252479 2040-05-17 U-1374 2025-04-04 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 9 · 351 observed states.
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 · 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