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. It is available from one supplier. 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. Four 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

Pharmacology for NDA: 021520

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520	NDA	Eli Lilly and Company	0002-3230	0002-3230-30	30 CAPSULE in 1 BOTTLE (0002-3230-30)
SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520	NDA	Eli Lilly and Company	0002-3231	0002-3231-30	30 CAPSULE in 1 BOTTLE (0002-3231-30)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE;EQ 6MG BASE
Approval Date:	Dec 24, 2003	TE:	AB	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	021520-005	Dec 24, 2003	⤷ Sign Up	⤷ Sign Up
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003	⤷ Sign Up	⤷ Sign Up
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-001	Apr 9, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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