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FDA Approval

Trintellix

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 3, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vortioxetine(20 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trintellix

Product Details

NDC Product Code
55154-0257
Application Number
NDA204447
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 13, 2018
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: TKS641KOAYClass: ACTIMQuantity: 20 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Hydroxypropyl Cellulose (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Trintellix

Product Details

NDC Product Code
55154-0256
Application Number
NDA204447
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 13, 2018
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: TKS641KOAYClass: ACTIMQuantity: 10 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Hydroxypropyl Cellulose (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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