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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. There are two patents protecting this drug and two Paragraph IV challenges. 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. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for NDA: 021520

Tradename:
SYMBYAX
Applicant:
Lilly
Ingredient:
fluoxetine hydrochloride; olanzapine
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021520

Mechanism of ActionSerotonin 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 3MG BASE
Approval Date:Apr 9, 2007TE:ABRLD:No
Regulatory Exclusivity Expiration:Oct 10, 2017
Regulatory Exclusivity Use:ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:6,960,577Patent Expiration:Nov 1, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS

Expired Orange Book Patents for NDA: 021520

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-001Apr 9, 20075,229,382*PED► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-002Dec 24, 2003522,982► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-003Dec 24, 20035,229,382*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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