Application 215358

Type
NDA
Sponsor
NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SCEMBLIXASCIMINIBTABLET;ORAL20MGNoNo
002SCEMBLIXASCIMINIBTABLET;ORAL40MGNoNo
003SCEMBLIXASCIMINIB HYDROCHLORIDETABLET;ORALEQ 100MG BASEYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215358-001SCEMBLIXASCIMINIB HYDROCHLORIDEEQ 20MG BASETABLET / ORALRLD2021-10-29
N215358-002SCEMBLIXASCIMINIB HYDROCHLORIDEEQ 40MG BASETABLET / ORALRLD2021-10-29
N215358-003SCEMBLIXASCIMINIB HYDROCHLORIDEEQ 100MG BASETABLET / ORALRLD, RS2024-04-18

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215358-00188291952035-10-29U-1374Drug substance2021-11-19
N215358-001114077352040-05-14Drug substance2022-08-23
N215358-001122524782040-05-14Drug product2025-04-04
N215358-001122524792040-05-17U-13742025-04-04
N215358-00288291952035-10-29U-1374Drug substance2021-11-19
N215358-002114077352040-05-14Drug substance2022-08-23
N215358-002122524782040-05-14Drug product2025-04-04
N215358-002122524792040-05-17U-13742025-04-04
N215358-00388291952035-10-29U-1374Drug substance2024-05-10
N215358-003114077352040-05-14Drug substance2024-05-10
N215358-003122524782040-05-14Drug product2025-04-04
N215358-003122524792040-05-17U-13742025-04-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 19 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215358-001NCE2026-10-29
N215358-001I-9532027-10-29
N215358-001I-9542027-10-29
N215358-001M-3182028-10-02
N215358-001ODE-3812028-10-29
N215358-001ODE-3822028-10-29
N215358-001ODE-4992031-10-29
N215358-001ODE-5002031-10-29
N215358-002NCE2026-10-29
N215358-002I-9532027-10-29
N215358-002I-9542027-10-29
N215358-002M-3182028-10-02
N215358-002ODE-3812028-10-29
N215358-002ODE-3822028-10-29
N215358-002ODE-4992031-10-29
N215358-002ODE-5002031-10-29
N215358-003NCE2026-10-29
N215358-003M-3182028-10-02
N215358-003ODE*2028-10-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29c2088c7a36db…
2026-10-15 13:18:302026-09N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD2021-10-29c2088c7a36db…
2026-10-15 13:18:302026-09N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD, RS2024-04-18c2088c7a36db…
2026-09-14 22:38:342026-08N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD2021-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD, RS2024-04-1884e616aacf4f…
2026-08-18 06:07:402026-07N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD2021-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD, RS2024-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD2021-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD, RS2024-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N215358-002SCEMBLIXEQ 40MG BASETABLET / ORALRLD, RS2021-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N215358-003SCEMBLIXEQ 100MG BASETABLET / ORALRLD2024-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215358-001SCEMBLIXEQ 20MG BASETABLET / ORALRLD2021-10-2979d66fd596c7…

Observed Orange Book patent history#

Patent history page 1 of 6 · 208 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N215358-00188291952035-10-29U-1374Drug substance2021-11-19c2088c7a36db…
2026-10-15 13:18:302026-09N215358-001114077352040-05-14Drug substance2022-08-23c2088c7a36db…
2026-10-15 13:18:302026-09N215358-001122524782040-05-14Drug product2025-04-04c2088c7a36db…
2026-10-15 13:18:302026-09N215358-001122524792040-05-17U-13742025-04-04c2088c7a36db…
2026-10-15 13:18:302026-09N215358-00288291952035-10-29U-1374Drug substance2021-11-19c2088c7a36db…
2026-10-15 13:18:302026-09N215358-002114077352040-05-14Drug substance2022-08-23c2088c7a36db…
2026-10-15 13:18:302026-09N215358-002122524782040-05-14Drug product2025-04-04c2088c7a36db…
2026-10-15 13:18:302026-09N215358-002122524792040-05-17U-13742025-04-04c2088c7a36db…
2026-10-15 13:18:302026-09N215358-00388291952035-10-29U-1374Drug substance2024-05-10c2088c7a36db…
2026-10-15 13:18:302026-09N215358-003114077352040-05-14Drug substance2024-05-10c2088c7a36db…
2026-10-15 13:18:302026-09N215358-003122524782040-05-14Drug product2025-04-04c2088c7a36db…
2026-10-15 13:18:302026-09N215358-003122524792040-05-17U-13742025-04-04c2088c7a36db…
2026-09-14 22:38:342026-08N215358-00188291952035-10-29U-1374Drug substance2021-11-1984e616aacf4f…
2026-09-14 22:38:342026-08N215358-001114077352040-05-14Drug substance2022-08-2384e616aacf4f…
2026-09-14 22:38:342026-08N215358-001122524782040-05-14Drug product2025-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N215358-001122524792040-05-17U-13742025-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N215358-00288291952035-10-29U-1374Drug substance2021-11-1984e616aacf4f…
2026-09-14 22:38:342026-08N215358-002114077352040-05-14Drug substance2022-08-2384e616aacf4f…
2026-09-14 22:38:342026-08N215358-002122524782040-05-14Drug product2025-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N215358-002122524792040-05-17U-13742025-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N215358-00388291952035-10-29U-1374Drug substance2024-05-1084e616aacf4f…
2026-09-14 22:38:342026-08N215358-003114077352040-05-14Drug substance2024-05-1084e616aacf4f…
2026-09-14 22:38:342026-08N215358-003122524782040-05-14Drug product2025-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N215358-003122524792040-05-17U-13742025-04-0484e616aacf4f…
2026-08-18 06:07:402026-07N215358-00188291952035-10-29U-1374Drug substance2021-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001114077352040-05-14Drug substance2022-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001122524782040-05-14Drug product2025-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001122524792040-05-17U-13742025-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-00288291952035-10-29U-1374Drug substance2021-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002114077352040-05-14Drug substance2022-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002122524782040-05-14Drug product2025-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002122524792040-05-17U-13742025-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-00388291952035-10-29U-1374Drug substance2024-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003114077352040-05-14Drug substance2024-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003122524782040-05-14Drug product2025-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003122524792040-05-17U-13742025-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215358-00188291952035-10-29U-1374Drug substance2021-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001114077352040-05-14Drug substance2022-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001122524782040-05-14Drug product2025-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001122524792040-05-17U-13742025-04-04011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 9 · 351 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N215358-001I-9542027-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001M-3182028-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001ODE-3812028-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001ODE-3822028-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001ODE-4992031-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-001ODE-5002031-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002NCE2026-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002I-9532027-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002I-9542027-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002M-3182028-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002ODE-3812028-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002ODE-3822028-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002ODE-4992031-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-002ODE-5002031-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003NCE2026-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003M-3182028-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N215358-003ODE*2028-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215358-001NCE2026-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001I-9532027-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001I-9542027-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001M-3182028-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001ODE-3812028-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001ODE-3822028-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001ODE-4992031-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-001ODE-5002031-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002NCE2026-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002I-9532027-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002I-9542027-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002M-3182028-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002ODE-3812028-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002ODE-3822028-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002ODE-4992031-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-002ODE-5002031-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-003NCE2026-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-003M-3182028-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215358-003ODE*2028-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-001NCE2026-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-001I-9532027-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-001I-9542027-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215358-001ODE-3812028-10-2931067a03dcf5…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-1091SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent
0078-1091SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent
0078-1091SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent
0078-1098SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent
0078-1098SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent
0078-1098SCEMBLIXasciminibNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84339SUPPL 2025-11-28
84328SUPPL 2025-11-28
84327SUPPL 2025-11-28
83656SUPPL 2025-10-03
83648SUPPL 2025-10-03
81022SUPPL 2025-02-05
80053SUPPL 2024-10-30
80052SUPPL 2024-10-30
80890SUPPL 2024-10-29
80040SUPPL 2024-10-29
79349SUPPL 2024-08-09
79343SUPPL 2024-08-08
76550SUPPL 2023-11-13
76543SUPPL 2023-11-09
74639SUPPL 2023-06-27
74629SUPPL 2023-06-27
72321SUPPL2022-10-13
72318SUPPL2022-10-13
69414ORIG2021-11-24
69413ORIG2021-11-24
69178ORIG2021-11-01
69177ORIG2021-11-01
69163ORIG2021-10-29
69162ORIG2021-10-29