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Last Updated: December 15, 2025

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. Five 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

Pharmacology for NDA: 020629

Mechanism of Action	DNA 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:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Sep 24, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020629

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,124,304	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,075,445	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,573,378	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,469,015	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,916,893	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,866,581	⤷ Get Started Free
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,840,763	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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