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Generated: May 23, 2019

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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 eight suppliers. 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 021253
Tradename:ZYPREXA
Applicant:Lilly
Ingredient:olanzapine
Patents:0
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)

Profile for product number 001

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

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