Home Applications 207968 Application 207968
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 90MG Yes No 002 JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 180MG Yes No 003 JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 360MG 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 N207968-001 JADENU SPRINKLE DEFERASIROX 90MG GRANULE / ORAL AB RLD 2017-05-18 N207968-002 JADENU SPRINKLE DEFERASIROX 180MG GRANULE / ORAL AB RLD 2017-05-18 N207968-003 JADENU SPRINKLE DEFERASIROX 360MG GRANULE / ORAL AB RLD, RS 2017-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 123 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 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 138 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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0713 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0720 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current 0078-0727 Jadenu deferasirox Novartis Pharmaceuticals Corporation NDA Current