Home Applications 022068 Application 022068
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TASIGNA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 200MG BASE Yes Yes 002 TASIGNA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Yes No 003 TASIGNA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022068-001 TASIGNA NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 N022068-002 TASIGNA NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 N022068-003 TASIGNA NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 42 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022068-001 8389537 2026-07-18 U-1374 2013-03-29 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 N022068-001 8389537*PED 2027-01-18 Pediatric extension N022068-001 8415363*PED 2027-01-18 Pediatric extension N022068-001 8501760*PED 2027-01-18 Pediatric extension N022068-001 8293756 2027-09-25 Drug product 2014-10-08 N022068-001 8293756*PED 2028-03-25 Pediatric extension N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 N022068-001 8163904*PED 2029-02-23 Pediatric extension N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-001 9061029*PED 2032-10-07 Pediatric extension N022068-002 8389537 2026-07-18 U-1374 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product N022068-002 8501760 2026-07-18 Drug product 2013-08-09 N022068-002 8389537*PED 2027-01-18 Pediatric extension N022068-002 8415363*PED 2027-01-18 Pediatric extension N022068-002 8501760*PED 2027-01-18 Pediatric extension N022068-002 8293756 2027-09-25 Drug product 2014-10-08 N022068-002 8293756*PED 2028-03-25 Pediatric extension N022068-002 8163904 2028-08-23 Drug substance, Drug product N022068-002 8163904*PED 2029-02-23 Pediatric extension N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-002 9061029*PED 2032-10-07 Pediatric extension N022068-003 8389537 2026-07-18 U-1374 2018-04-12 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 N022068-003 8389537*PED 2027-01-18 Pediatric extension N022068-003 8415363*PED 2027-01-18 Pediatric extension N022068-003 8501760*PED 2027-01-18 Pediatric extension N022068-003 8293756 2027-09-25 Drug product 2018-04-12 N022068-003 8293756*PED 2028-03-25 Pediatric extension N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 N022068-003 8163904*PED 2029-02-23 Pediatric extension N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 N022068-003 9061029 2032-04-07 U-3231 Drug substance 2018-04-12 N022068-003 9061029*PED 2032-10-07 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 4 · 126 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 2026-08-18 06:07:40 2026-07 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 48 · 1,893 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022068-001 8389537 2026-07-18 U-1374 2013-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8389537*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8415363*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8501760*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8293756 2027-09-25 Drug product 2014-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8293756*PED 2028-03-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 8163904*PED 2029-02-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-001 9061029*PED 2032-10-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8389537 2026-07-18 U-1374 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8501760 2026-07-18 Drug product 2013-08-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8389537*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8415363*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8501760*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8293756 2027-09-25 Drug product 2014-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8293756*PED 2028-03-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8163904 2028-08-23 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 8163904*PED 2029-02-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 9061029*PED 2032-10-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8389537 2026-07-18 U-1374 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8389537*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8415363*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8501760*PED 2027-01-18 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8293756 2027-09-25 Drug product 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8293756*PED 2028-03-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 8163904*PED 2029-02-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 19 · 750 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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0526 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0592 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current 0078-0951 Tasigna nilotinib Novartis Pharmaceuticals Corporation NDA Current