Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078901

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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: A078901
Product Number: 005
Approval Date: Nov 16, 2012
Applicant Holder Full Name: EPIC PHARMA LLC
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: A078901
Product Number: 001
Approval Date: Nov 16, 2012
Applicant Holder Full Name: EPIC PHARMA LLC
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: A078901
Product Number: 003
Approval Date: Nov 16, 2012
Applicant Holder Full Name: EPIC PHARMA LLC
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: A078901
Product Number: 002
Approval Date: Nov 16, 2012
Applicant Holder Full Name: EPIC PHARMA LLC
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: A078901
Product Number: 004
Approval Date: Nov 16, 2012
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information