Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021520

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SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 3MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: SYMBYAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021520
Product Number: 001
Approval Date: Apr 9, 2007
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 6MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: SYMBYAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021520
Product Number: 002
Approval Date: Dec 24, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 25MG BASE;EQ 12MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: SYMBYAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE;EQ 12MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021520
Product Number: 004
Approval Date: Dec 24, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 50MG BASE;EQ 6MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: SYMBYAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE;EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021520
Product Number: 003
Approval Date: Dec 24, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE)
EQ 50MG BASE;EQ 12MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Proprietary Name: SYMBYAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE;EQ 12MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021520
Product Number: 005
Approval Date: Dec 24, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information