Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076435
Company: FOUGERA PHARMS

Products on ANDA 076435

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 076435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076435ltr.pdf

Therapeutic Equivalents for ANDA 076435

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
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	TARO
LOPROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	Yes	AB	018748	MEDIMETRIKS PHARMS