Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091595
Company: GLENMARK PHARMS INC

Products on ANDA 091595

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091595

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/2012	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
12/01/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091595

CICLOPIROX

GEL;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%	GEL;TOPICAL	Prescription	No	AB	077896	FOUGERA PHARMS
CICLOPIROX	CICLOPIROX	0.77%	GEL;TOPICAL	Prescription	No	AB	091595	GLENMARK PHARMS INC
CICLOPIROX	CICLOPIROX	0.77%	GEL;TOPICAL	Prescription	No	AB	078266	PADAGIS US