Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 077742

Expand all

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 3MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077742
Product Number: 001
Approval Date: Nov 2, 2012
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 6MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077742
Product Number: 002
Approval Date: Nov 2, 2012
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 12MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 12MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077742
Product Number: 003
Approval Date: Nov 2, 2012
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 50MG BASE;EQ 6MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE;EQ 6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077742
Product Number: 004
Approval Date: Nov 2, 2012
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 50MG BASE;EQ 12MG BASE
Marketing Status: Prescription
Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE;EQ 12MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077742
Product Number: 005
Approval Date: Nov 2, 2012
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English