Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078463
Company: COSETTE PHARMS NC

Products on ANDA 078463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2010	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
05/21/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078463

CICLOPIROX

CREAM;TOPICAL; 0.77%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	No	AB	078463	COSETTE PHARMS NC
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	No	AB	076435	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	No	AB	090273	GLENMARK PHARMS
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	No	AB	077364	PADAGIS ISRAEL
CICLOPIROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	No	AB	076790	SUN PHARMA CANADA
LOPROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	Yes	AB	018748	EUROFARMA