Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204114

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MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE)
EQ 0.5MG
Marketing Status: Prescription

Active Ingredient: TRAMETINIB DIMETHYL SULFOXIDE
Proprietary Name: MEKINIST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204114
Product Number: 001
Approval Date: May 29, 2013
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE)
EQ 2MG
Marketing Status: Prescription

Active Ingredient: TRAMETINIB DIMETHYL SULFOXIDE
Proprietary Name: MEKINIST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204114
Product Number: 003
Approval Date: May 29, 2013
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE)
EQ 1MG
Marketing Status: Discontinued

Active Ingredient: TRAMETINIB DIMETHYL SULFOXIDE
Proprietary Name: MEKINIST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204114
Product Number: 002
Approval Date: May 29, 2013
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information