Product Details for NDA 204114
MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE)
EQ 0.5MG
Marketing Status: Prescription
EQ 2MG
Marketing Status: Prescription
EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
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)
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
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)
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
EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMETINIB DIMETHYL SULFOXIDE
Proprietary Name: MEKINIST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
Proprietary Name: MEKINIST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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