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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020629


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NDA 020629 describes DENAVIR, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the DENAVIR profile page.

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the penciclovir profile page.
Summary for 020629
Tradename:DENAVIR
Applicant:Mylan
Ingredient:penciclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020629
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 020629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DENAVIR penciclovir CREAM;TOPICAL 020629 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-0896 0378-0896-55 1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBE
DENAVIR penciclovir CREAM;TOPICAL 020629 NDA Mylan Pharmaceuticals Inc. 0378-9720 0378-9720-55 1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 24, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020629

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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