Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090146
Company: FOUGERA PHARMS

Products on ANDA 090146

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090146

CICLOPIROX

SHAMPOO;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090490	ACTAVIS MID ATLANTIC
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	209975	ENCUBE
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090146	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	078594	PADAGIS US
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090269	SUN PHARMA CANADA