MedPath
FDA Approval

Symbyax

August 18, 2023

HUMAN PRESCRIPTION DRUG LABEL

Olanzapine(3 mg in 1 1)
Fluoxetine(25 mg in 1 1)

Products (2)

Symbyax

0002-3230

NDA021520

NDA (C73594)

ORAL

December 23, 2021

STARCH, CornInactive
Code: O8232NY3SJClass: IACT
Code: N7U69T4SZRClass: ACTIBQuantity: 3 mg in 1 1
DimethiconeInactive
Code: 92RU3N3Y1OClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: I9W7N6B1KJClass: ACTIMQuantity: 25 mg in 1 1

Symbyax

0002-3231

NDA021520

NDA (C73594)

ORAL

December 23, 2021

Code: N7U69T4SZRClass: ACTIBQuantity: 6 mg in 1 1
Code: I9W7N6B1KJClass: ACTIMQuantity: 25 mg in 1 1
STARCH, CornInactive
Code: O8232NY3SJClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
DimethiconeInactive
Code: 92RU3N3Y1OClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
© Copyright 2025. All Rights Reserved by MedPath