Home NDC 70709-192 CAVHANZA
Product NDC 70709-192
11-digit product format 707090192
Labeler code 70709
Product ID 70709-192_8991c94b-a4c1-46f8-aafe-a106aba4f8cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nilotinib
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Cycle Pharmaceuticals Ltd
Application NDA217379
Marketing category NDA
Marketing start 2026-06-30
Substance NILOTINIB
Active strength 80 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217379-001 CAVHANZA NILOTINIB 60MG TABLET, ORALLY DISINTEGRATING / ORAL RLD 2026-05-29 N217379-002 CAVHANZA NILOTINIB 80MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2026-05-29
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 N217379-001 11389450 2041-01-29 U-4556 2026-06-26 N217379-001 11389450 2041-01-29 U-4557 2026-06-26 N217379-001 12016861 2041-01-29 U-4554 2026-06-26 N217379-001 12016861 2041-01-29 U-4555 2026-06-26 N217379-001 12029740 2041-01-29 Drug product 2026-06-26 N217379-001 11559485 2041-04-30 Drug product 2026-06-26 N217379-002 11389450 2041-01-29 U-4556 2026-06-26 N217379-002 11389450 2041-01-29 U-4557 2026-06-26 N217379-002 12016861 2041-01-29 U-4554 2026-06-26 N217379-002 12016861 2041-01-29 U-4555 2026-06-26 N217379-002 12029740 2041-01-29 Drug product 2026-06-26 N217379-002 11559485 2041-04-30 Drug product 2026-06-26
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.
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 2026-09-14 22:38:34 2026-08 N217379-001 CAVHANZA 60MG TABLET, ORALLY DISINTEGRATING / ORAL RLD 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 CAVHANZA 80MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2026-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217379-001 CAVHANZA 60MG TABLET, ORALLY DISINTEGRATING / ORAL RLD 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 CAVHANZA 80MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2026-05-29 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 CAVHANZA 60MG TABLET, ORALLY DISINTEGRATING / ORAL RLD 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 CAVHANZA 80MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2026-05-29 a50c72e98297…
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 2026-09-14 22:38:34 2026-08 N217379-001 11389450 2041-01-29 U-4556 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-001 11389450 2041-01-29 U-4557 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-001 12016861 2041-01-29 U-4554 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-001 12016861 2041-01-29 U-4555 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-001 12029740 2041-01-29 Drug product 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-001 11559485 2041-04-30 Drug product 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 11389450 2041-01-29 U-4556 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 11389450 2041-01-29 U-4557 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 12016861 2041-01-29 U-4554 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 12016861 2041-01-29 U-4555 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 12029740 2041-01-29 Drug product 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217379-002 11559485 2041-04-30 Drug product 2026-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217379-001 11389450 2041-01-29 U-4556 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-001 11389450 2041-01-29 U-4557 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-001 12016861 2041-01-29 U-4554 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-001 12016861 2041-01-29 U-4555 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-001 12029740 2041-01-29 Drug product 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-001 11559485 2041-04-30 Drug product 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 11389450 2041-01-29 U-4556 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 11389450 2041-01-29 U-4557 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 12016861 2041-01-29 U-4554 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 12016861 2041-01-29 U-4555 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 12029740 2041-01-29 Drug product 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217379-002 11559485 2041-04-30 Drug product 2026-06-26 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 11389450 2041-01-29 U-4556 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 11389450 2041-01-29 U-4557 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 12016861 2041-01-29 U-4554 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 12016861 2041-01-29 U-4555 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 12029740 2041-01-29 Drug product 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-001 11559485 2041-04-30 Drug product 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 11389450 2041-01-29 U-4556 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 11389450 2041-01-29 U-4557 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 12016861 2041-01-29 U-4554 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 12016861 2041-01-29 U-4555 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 12029740 2041-01-29 Drug product 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217379-002 11559485 2041-04-30 Drug product 2026-06-26 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CAVHANZA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NILOTINIB 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F41401512X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2747509 Internal RxNorm lookup 2747516 Internal RxNorm lookup 2747518 Internal RxNorm lookup 2747520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAVHANZA NILOTINIB Cycle Pharmaceuticals Ltd 98b197ea-bca4-427e-8737-97f70a3262bc 2026-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 217379 application number: NDA217379 ndc (product): 70709-192
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70709-192-12 70709019212 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-192-12) 2026-06-30 No No Current