Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090490
Company: ACTAVIS MID ATLANTIC

Products on ANDA 090490

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 090490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090490s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/30/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090490

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	090146	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	078594	PADAGIS US
CICLOPIROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	No	AT	090269	TARO
LOPROX	CICLOPIROX	1%	SHAMPOO;TOPICAL	Prescription	Yes	AT	021159	BAUSCH