Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022173

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ZYPREXA RELPREVV (OLANZAPINE PAMOATE)
EQ 210MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OLANZAPINE PAMOATE
Proprietary Name: ZYPREXA RELPREVV
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: EQ 210MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022173
Product Number: 001
Approval Date: Dec 11, 2009
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYPREXA RELPREVV (OLANZAPINE PAMOATE)
EQ 300MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OLANZAPINE PAMOATE
Proprietary Name: ZYPREXA RELPREVV
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: EQ 300MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022173
Product Number: 002
Approval Date: Dec 11, 2009
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYPREXA RELPREVV (OLANZAPINE PAMOATE)
EQ 405MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OLANZAPINE PAMOATE
Proprietary Name: ZYPREXA RELPREVV
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: EQ 405MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022173
Product Number: 003
Approval Date: Dec 11, 2009
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information