Details for New Drug Application (NDA): 218922

NDA 218922 describes NILOTINIB D-TARTRATE, which is a drug marketed by Cipla and is included in one NDA. It is available from two suppliers. Additional details are available on the NILOTINIB D-TARTRATE profile page.

The generic ingredient in NILOTINIB D-TARTRATE is nilotinib d-tartrate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nilotinib d-tartrate profile page.

Summary for 218922

Tradename:	NILOTINIB D-TARTRATE
Applicant:	Cipla
Ingredient:	nilotinib d-tartrate
Patents:	0

Pharmacology for NDA: 218922

Mechanism of Action

Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Suppliers and Packaging for NDA: 218922

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922	NDA	Cipla USA Inc.	69097-030	69097-030-08	120 CAPSULE in 1 BOTTLE, PLASTIC (69097-030-08)
NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922	NDA	Cipla USA Inc.	69097-030	69097-030-63	7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Feb 19, 2025	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Feb 19, 2025	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Feb 19, 2025	TE:		RLD:	Yes

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