Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212710
Company: TEVA PHARMS USA

Products on ANDA 212710

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 212710

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212710Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212710

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	212368	PADAGIS ISRAEL
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	212710	TEVA PHARMS USA
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	216981	TORRENT