Home NDC 70709-192-12 CAVHANZA
Product NDC 70709-192
Requested package NDC 70709-192-12
11-digit product format 707090192
Labeler code 70709
Product ID 70709-192_5bfb2610-4fa7-4f4c-bfba-7bed50e63ef3
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 44 .
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 2026-10-15 13:18:30 2026-09 N217379-001 CAVHANZA 60MG TABLET, ORALLY DISINTEGRATING / ORAL RLD 2026-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 CAVHANZA 80MG TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2026-05-29 c2088c7a36db…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# Patent history page 1 of 2 · 48 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 N217379-001 11389450 2041-01-29 U-4556 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-001 11389450 2041-01-29 U-4557 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-001 12016861 2041-01-29 U-4554 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-001 12016861 2041-01-29 U-4555 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-001 12029740 2041-01-29 Drug product 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-001 11559485 2041-04-30 Drug product 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 11389450 2041-01-29 U-4556 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 11389450 2041-01-29 U-4557 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 12016861 2041-01-29 U-4554 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 12016861 2041-01-29 U-4555 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 12029740 2041-01-29 Drug product 2026-06-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217379-002 11559485 2041-04-30 Drug product 2026-06-26 c2088c7a36db…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…
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.
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