Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021411

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STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 002
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 18MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 18MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 003
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 004
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 005
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021411
Product Number: 006
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 80MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 007
Approval Date: Feb 14, 2005
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021411
Product Number: 008
Approval Date: Feb 14, 2005
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

STRATTERA (ATOMOXETINE HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Discontinued

Active Ingredient: ATOMOXETINE HYDROCHLORIDE
Proprietary Name: STRATTERA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021411
Product Number: 001
Approval Date: Nov 26, 2002
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information