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Last Updated: March 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021319


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NDA 021319 describes AVODART, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the AVODART profile page.

The generic ingredient in AVODART is dutasteride. There are eighteen drug master file entries for this compound. Additional details are available on the dutasteride profile page.
Summary for 021319
Tradename:AVODART
Applicant:Glaxosmithkline
Ingredient:dutasteride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021319
Paragraph IV (Patent) Challenges for 021319
Tradename Dosage Ingredient NDA Submissiondate
AVODART CAPSULE;ORAL dutasteride 021319 2007-10-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Nov 20, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021319

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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