Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214100
Company: AMNEAL

Products on ANDA 214100

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214100

PENCICLOVIR

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DENAVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	Yes	AB	020629	MYLAN
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	214100	AMNEAL
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	212368	PADAGIS ISRAEL
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	212710	TEVA PHARMS USA