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-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
2026-10-15 13:18:302026-09N217379-001CAVHANZA60MGTABLET, ORALLY DISINTEGRATING / ORALRLD2026-05-29c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002CAVHANZA80MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2026-05-29c2088c7a36db…
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#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N217379-001113894502041-01-29U-45562026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-001113894502041-01-29U-45572026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-001120168612041-01-29U-45542026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-001120168612041-01-29U-45552026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-001120297402041-01-29Drug product2026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-001115594852041-04-30Drug product2026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002113894502041-01-29U-45562026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002113894502041-01-29U-45572026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002120168612041-01-29U-45542026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002120168612041-01-29U-45552026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002120297402041-01-29Drug product2026-06-26c2088c7a36db…
2026-10-15 13:18:302026-09N217379-002115594852041-04-30Drug product2026-06-26c2088c7a36db…
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…

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
NILOTINIB80 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70709-192-1270709019212112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70709-192-12) 2026-06-30NoNoCurrent