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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021411


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NDA 021411 describes STRATTERA, which is a drug marketed by Lilly and is included in one NDA. It is available from two suppliers. Additional details are available on the STRATTERA profile page.

The generic ingredient in STRATTERA is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.
Summary for 021411
Tradename:STRATTERA
Applicant:Lilly
Ingredient:atomoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021411
Medical Subject Heading (MeSH) Categories for 021411
Suppliers and Packaging for NDA: 021411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411 NDA Eli Lilly and Company 0002-3227 0002-3227-30 30 CAPSULE in 1 BOTTLE (0002-3227-30)
STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411 NDA Eli Lilly and Company 0002-3228 0002-3228-30 30 CAPSULE in 1 BOTTLE (0002-3228-30)
Paragraph IV (Patent) Challenges for 021411
Tradename Dosage Ingredient NDA Submissiondate
STRATTERA CAPSULE;ORAL atomoxetine hydrochloride 021411 2007-05-29

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Nov 26, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 26, 2002TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength18MG
Approval Date:Nov 26, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021411

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-006 Nov 26, 2002   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-001 Nov 26, 2002   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-008 Feb 14, 2005   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-004 Nov 26, 2002   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-003 Nov 26, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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