Last Updated: September 28, 2026

Details for New Drug Application (NDA): 216981

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NDA 216981 describes PENCICLOVIR, which is a drug marketed by Amneal, Padagis Israel, Teva Pharms Usa, and Torrent, and is included in four NDAs. It is available from three suppliers. Additional details are available on the PENCICLOVIR profile page.

The generic ingredient in PENCICLOVIR is penciclovir. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

Summary for 216981

Tradename:	PENCICLOVIR
Applicant:	Torrent
Ingredient:	penciclovir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Aug 7, 2023	TE:	BX	RLD:	No

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