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Details for New Drug Application (NDA): 021253

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NDA 021253 describes ZYPREXA, which is a drug marketed by Lilly and Eli Lilly Co and is included in four NDAs. It is available from twelve suppliers. There are two patents protecting this drug. Additional details are available on the ZYPREXA profile page.

The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.

Summary for NDA: 021253

Tradename:
ZYPREXA
Applicant:
Lilly
Ingredient:
olanzapine
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021253

Suppliers and Packaging for NDA: 021253

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYPREXA
olanzapine
INJECTABLE;INTRAMUSCULAR 021253 NDA Eli Lilly and Company 0002-7597 0002-7597-01 1 VIAL in 1 CARTON (0002-7597-01) > 2 mL in 1 VIAL
ZYPREXA
olanzapine
INJECTABLE;INTRAMUSCULAR 021253 NDA TYA Pharmaceuticals 64725-7597 64725-7597-1 10 mL in 1 VIAL (64725-7597-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength10MG/VIAL
Approval Date:Mar 29, 2004TE:APRLD:Yes

Expired Orange Book Patents for NDA: 021253

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ZYPREXA
olanzapine
INJECTABLE;INTRAMUSCULAR021253-001Mar 29, 20045,229,382*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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