Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077676
Company: PADAGIS ISRAEL

Products on ANDA 077676

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 077676

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2006	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
04/10/2025	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 077676

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
LOPROX	CICLOPIROX	0.77%	SUSPENSION;TOPICAL	Prescription	Yes	AB	019824	EUROFARMA