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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

Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for NDA: 021253

Suppliers and Packaging for NDA: 021253

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
INJECTABLE;INTRAMUSCULAR 021253 NDA TYA Pharmaceuticals 64725-7597 64725-7597-1 10 mL in 1 VIAL (64725-7597-1)

Summary for product number 001

Approval Date:Mar 29, 2004TE:APRLD:Yes

Expired Orange Book Patents for NDA: 021253

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INTRAMUSCULAR021253-001Mar 29, 20045,229,382*PED<subscribe>
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