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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204447

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TRINTELLIX (VORTIOXETINE HYDROBROMIDE)
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: VORTIOXETINE HYDROBROMIDE
Proprietary Name: TRINTELLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204447
Product Number: 001
Approval Date: Sep 30, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRINTELLIX (VORTIOXETINE HYDROBROMIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: VORTIOXETINE HYDROBROMIDE
Proprietary Name: TRINTELLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204447
Product Number: 002
Approval Date: Sep 30, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRINTELLIX (VORTIOXETINE HYDROBROMIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: VORTIOXETINE HYDROBROMIDE
Proprietary Name: TRINTELLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204447
Product Number: 004
Approval Date: Sep 30, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRINTELLIX (VORTIOXETINE HYDROBROMIDE)
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VORTIOXETINE HYDROBROMIDE
Proprietary Name: TRINTELLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N204447
Product Number: 003
Approval Date: Sep 30, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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