Nilotinib - Generic Drug Details

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Generic filers with tentative approvals for NILOTINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Get Started Free	⤷ Get Started Free	200MG	CAPSULE
⤷ Get Started Free	⤷ Get Started Free	150MG	CAPSULE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for nilotinib

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes	8,293,756*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Apotex	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	203640-001	Jan 5, 2024	AB	RX	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes	8,163,904*PED	⤷ Get Started Free			Y	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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