Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076422
Company: FOUGERA PHARMS

Products on ANDA 076422

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2004	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76422ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076422_CiclopiroxTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076422

CICLOPIROX

SUSPENSION;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%	SUSPENSION;TOPICAL	Prescription	No	AB	076422	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	0.77%	SUSPENSION;TOPICAL	Prescription	No	AB	077676	PADAGIS ISRAEL
CICLOPIROX	CICLOPIROX	0.77%	SUSPENSION;TOPICAL	Prescription	No	AB	077092	TARO
LOPROX	CICLOPIROX	0.77%	SUSPENSION;TOPICAL	Prescription	Yes	AB	019824	MEDIMETRIKS PHARMS