Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078594
Company: PADAGIS US

Products on ANDA 078594

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 078594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2010	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
10/14/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078594

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