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Details for New Drug Application (NDA): 020629

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NDA 020629 describes DENAVIR, which is a drug marketed by Denco Asset and is included in one NDA. It is available from five suppliers. There are four patents protecting this drug. Additional details are available on the DENAVIR profile page.

The generic ingredient in DENAVIR is penciclovir. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

Summary for NDA: 020629

Tradename:
DENAVIR
Applicant:
Denco Asset
Ingredient:
penciclovir
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 020629

Ingredient-typeNucleoside Analog
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 Prestium Pharma, Inc. 40076-624 40076-624-01 .5 g in 1 POUCH (40076-624-01)
DENAVIR
penciclovir
CREAM;TOPICAL 020629 NDA Prestium Pharma, Inc. 40076-624 40076-624-05 1 TUBE in 1 CARTON (40076-624-05) > 5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 24, 1996TE:RLD:Yes
Patent:5,840,763Patent Expiration:Sep 1, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
Patent:5,916,893Patent Expiration:Sep 1, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
Patent:6,469,015Patent Expiration:Oct 22, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS

Expired Orange Book Patents for NDA: 020629

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Denco Asset
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 19965,075,445► subscribe
Denco Asset
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 19966,124,304► subscribe
Denco Asset
DENAVIR
penciclovir
CREAM;TOPICAL020629-001Sep 24, 19965,916,893► subscribe
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