U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020592

Expand all

ZYPREXA (OLANZAPINE)
2.5MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020592
Product Number: 001
Approval Date: Sep 30, 1996
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA (OLANZAPINE)
5MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020592
Product Number: 002
Approval Date: Sep 30, 1996
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA (OLANZAPINE)
7.5MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020592
Product Number: 003
Approval Date: Sep 30, 1996
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA (OLANZAPINE)
10MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020592
Product Number: 004
Approval Date: Sep 30, 1996
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA (OLANZAPINE)
15MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020592
Product Number: 005
Approval Date: Sep 9, 1997
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ZYPREXA (OLANZAPINE)
20MG
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: ZYPREXA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020592
Product Number: 006
Approval Date: Sep 9, 1997
Applicant Holder Full Name: CHEPLAPHARM REGISTRATION GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top