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Details for New Drug Application (NDA): 204114

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NDA 204114 describes MEKINIST, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the MEKINIST profile page.

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. Two suppliers are listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.

Summary for NDA: 204114

Tradename:
MEKINIST
Applicant:
Novartis Pharms Corp
Ingredient:
trametinib dimethyl sulfoxide
Patents:6

Pharmacology for NDA: 204114

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 204114

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL 204114 NDA Novartis Pharmaceuticals Corporation 0078-0666 0078-0666-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15)
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL 204114 NDA Novartis Pharmaceuticals Corporation 0078-0668 0078-0668-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG
Approval Date:May 29, 2013TE:RLD:No
Patent:7,378,423Patent Expiration:Sep 13, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:8,580,304Patent Expiration:Jan 28, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:9,155,706Patent Expiration:Jan 28, 2032Product Flag?YSubstance Flag?Delist 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.

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