Product Details for ANDA 078901
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 3MG BASE
Marketing Status: Prescription
EQ 25MG BASE;EQ 6MG BASE
Marketing Status: Prescription
EQ 25MG BASE;EQ 12MG BASE
Marketing Status: Prescription
EQ 50MG BASE;EQ 6MG BASE
Marketing Status: Prescription
EQ 50MG BASE;EQ 12MG BASE
Marketing Status: Prescription
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)
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
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)
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
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)
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
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)
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
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
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