Symbyax
These highlights do not include all the information needed to use SYMBYAX safely and effectively. See full prescribing information for SYMBYAX.SYMBYAX (olanzapine and fluoxetine) capsules for oral useInitial U.S. Approval: 2003
Approved
Approval ID
6b28c424-0b7e-4b75-b090-f116b113554e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Olanzapine and Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-3230
Application NumberNDA021520
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine and Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (9)
STARCH, CornInactive
Code: O8232NY3SJ
Classification: IACT
OlanzapineActive
Quantity: 3 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Fluoxetine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
Olanzapine and Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-3231
Application NumberNDA021520
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine and Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (10)
OlanzapineActive
Quantity: 6 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Fluoxetine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
STARCH, CornInactive
Code: O8232NY3SJ
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT