Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078172
Company: ACELLA

Products on ANDA 078172

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078172

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078172ltr.pdf

Therapeutic Equivalents for ANDA 078172

CICLOPIROX

SOLUTION;TOPICAL; 8%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078172	ACELLA
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078046	CHARTWELL RX
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	077687	ENCUBE
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	077623	PADAGIS US
CICLOPIROX	CICLOPIROX	8%	SOLUTION;TOPICAL	Prescription	No	AT	078124	RISING