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Generated: January 22, 2019

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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. It is available from one supplier. 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. Twenty-five suppliers are listed 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
Pharmacology for NDA: 021319
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 021319
Suppliers and Packaging for NDA: 021319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVODART dutasteride CAPSULE;ORAL 021319 NDA GlaxoSmithKline LLC 0173-0712 0173-0712-04 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0712-04)
AVODART dutasteride CAPSULE;ORAL 021319 NDA GlaxoSmithKline LLC 0173-0712 0173-0712-15 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0173-0712-15)

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

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