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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 021520

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NDA 021520 describes SYMBYAX, which is a drug marketed by Lilly and is included in one NDA. Additional details are available on the SYMBYAX profile page.

The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for 021520

Tradename:	SYMBYAX
Applicant:	Lilly
Ingredient:	fluoxetine hydrochloride; olanzapine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE;EQ 3MG BASE
Approval Date:	Apr 9, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE;EQ 6MG BASE
Approval Date:	Dec 24, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE;EQ 6MG BASE
Approval Date:	Dec 24, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021520

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003	5,945,416	⤷ Get Started Free
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-001	Apr 9, 2007	5,229,382*PED	⤷ Get Started Free
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003	5,945,416	⤷ Get Started Free
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003	6,960,577	⤷ Get Started Free
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003	5,945,416	⤷ Get Started Free
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003	6,960,577	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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