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Details for New Drug Application (NDA): 205266

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NDA 205266 describes ODOMZO, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ODOMZO profile page.

The generic ingredient in ODOMZO is sonidegib phosphate. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.

Summary for NDA: 205266

Tradename:
ODOMZO
Applicant:
Novartis Pharms Corp
Ingredient:
sonidegib phosphate
Patents:2

Pharmacology for NDA: 205266

Suppliers and Packaging for NDA: 205266

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ODOMZO
sonidegib phosphate
CAPSULE;ORAL 205266 NDA Novartis Pharmaceuticals Corporation 0078-0645 0078-0645-15 30 CAPSULE in 1 BOTTLE (0078-0645-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Jul 24, 2015TE:RLD:Yes
Patent:8,063,043Patent Expiration:Sep 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jul 24, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:8,178,563Patent Expiration:Feb 6, 2029Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF BASAL CELL CARCINOMA


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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.

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