MedPath
FDA Product

Symbyax

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Symbyax

0002-3230

Regulatory Information

0002-3230

NDA021520

C73594

December 23, 2021

USA

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

HUMAN PRESCRIPTION DRUG LABEL

83

Company Information

006421325

Active Ingredients

Olanzapine

Quantity: 3 mg in 1 1

Code: N7U69T4SZR

Class Code: ACTIB

Fluoxetine hydrochloride

Quantity: 25 mg in 1 1

Code: I9W7N6B1KJ

Class Code: ACTIM

Inactive Ingredients

STARCH, Corn

Code: O8232NY3SJ

Class Code: IACT

Dimethicone

Code: 92RU3N3Y1O

Class Code: IACT

Gelatin, Unspecified

Code: 2G86QN327L

Class Code: IACT

sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

Olanzapine

Code: N7U69T4SZR

Fluoxetine

Code: 01K63SUP8D

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