CAVHANZA

Product NDC
70709-191
11-digit product format
707090191
Labeler code
70709
Product ID
70709-191_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
60 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217379-001CAVHANZANILOTINIB60MGTABLET, ORALLY DISINTEGRATING / ORALRLD2026-05-29
N217379-002CAVHANZANILOTINIB80MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2026-05-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217379-001113894502041-01-29U-45562026-06-26
N217379-001113894502041-01-29U-45572026-06-26
N217379-001120168612041-01-29U-45542026-06-26
N217379-001120168612041-01-29U-45552026-06-26
N217379-001120297402041-01-29Drug product2026-06-26
N217379-001115594852041-04-30Drug product2026-06-26
N217379-002113894502041-01-29U-45562026-06-26
N217379-002113894502041-01-29U-45572026-06-26
N217379-002120168612041-01-29U-45542026-06-26
N217379-002120168612041-01-29U-45552026-06-26
N217379-002120297402041-01-29Drug product2026-06-26
N217379-002115594852041-04-30Drug product2026-06-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217379-001CAVHANZA60MGTABLET, ORALLY DISINTEGRATING / ORALRLD2026-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N217379-002CAVHANZA80MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2026-05-2984e616aacf4f…
2026-08-18 06:07:402026-07N217379-001CAVHANZA60MGTABLET, ORALLY DISINTEGRATING / ORALRLD2026-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002CAVHANZA80MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2026-05-29caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001CAVHANZA60MGTABLET, ORALLY DISINTEGRATING / ORALRLD2026-05-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002CAVHANZA80MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2026-05-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217379-001113894502041-01-29U-45562026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-001113894502041-01-29U-45572026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-001120168612041-01-29U-45542026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-001120168612041-01-29U-45552026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-001120297402041-01-29Drug product2026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-001115594852041-04-30Drug product2026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002113894502041-01-29U-45562026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002113894502041-01-29U-45572026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002120168612041-01-29U-45542026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002120168612041-01-29U-45552026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002120297402041-01-29Drug product2026-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N217379-002115594852041-04-30Drug product2026-06-2684e616aacf4f…
2026-08-18 06:07:402026-07N217379-001113894502041-01-29U-45562026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-001113894502041-01-29U-45572026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-001120168612041-01-29U-45542026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-001120168612041-01-29U-45552026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-001120297402041-01-29Drug product2026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-001115594852041-04-30Drug product2026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002113894502041-01-29U-45562026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002113894502041-01-29U-45572026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002120168612041-01-29U-45542026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002120168612041-01-29U-45552026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002120297402041-01-29Drug product2026-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217379-002115594852041-04-30Drug product2026-06-26caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001113894502041-01-29U-45562026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001113894502041-01-29U-45572026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001120168612041-01-29U-45542026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001120168612041-01-29U-45552026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001120297402041-01-29Drug product2026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-001115594852041-04-30Drug product2026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002113894502041-01-29U-45562026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002113894502041-01-29U-45572026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002120168612041-01-29U-45542026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002120168612041-01-29U-45552026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002120297402041-01-29Drug product2026-06-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217379-002115594852041-04-30Drug product2026-06-26a50c72e98297…

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
IngredientStrength
NILOTINIB60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F41401512XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747509Internal RxNorm lookup
2747516Internal RxNorm lookup
2747518Internal RxNorm lookup
2747520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98b197ea-bca4-427e-8737-97f70a3262bcAvailable on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAVHANZANILOTINIBCycle Pharmaceuticals Ltd98b197ea-bca4-427e-8737-97f70a3262bc2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217379
application number: NDA217379
ndc (product): 70709-191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70709-191-1270709019112112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-191-12) 2026-06-30NoNoCurrent