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Details for New Drug Application (NDA): 022068

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NDA 022068 describes TASIGNA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TASIGNA profile page.

The generic ingredient in TASIGNA is nilotinib hydrochloride monohydrate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride monohydrate profile page.

Summary for NDA: 022068

nilotinib hydrochloride monohydrate

Pharmacology for NDA: 022068

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 022068

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nilotinib hydrochloride monohydrate
CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 0078-0526-51 28 CAPSULE in 1 BLISTER PACK (0078-0526-51)
nilotinib hydrochloride monohydrate
CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 0078-0526-87 4 BLISTER PACK in 1 CARTON (0078-0526-87) > 28 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Oct 29, 2007TE:RLD:Yes
Patent:8,163,904Patent Expiration:Aug 23, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:8,293,756Patent Expiration:Sep 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,501,760Patent Expiration:Jul 18, 2026Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.