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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021086

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ZYPREXA ZYDIS (OLANZAPINE)
5MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA ZYDIS
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021086
Product Number: 001
Approval Date: Apr 6, 2000
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA ZYDIS (OLANZAPINE)
10MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA ZYDIS
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021086
Product Number: 002
Approval Date: Apr 6, 2000
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA ZYDIS (OLANZAPINE)
15MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA ZYDIS
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021086
Product Number: 003
Approval Date: Apr 6, 2000
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA ZYDIS (OLANZAPINE)
20MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA ZYDIS
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021086
Product Number: 004
Approval Date: Apr 6, 2000
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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