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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078233
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078233s000ltr.pdf

CICLOPIROX

SOLUTION;TOPICAL; 8%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078172 ACELLA
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078270 AKORN
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078046 CHARTWELL RX
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078233 COSETTE
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 077623 PADAGIS US
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078124 RISING
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078144 TARO PHARM INDS
PENLAC CICLOPIROX 8% SOLUTION;TOPICAL Prescription Yes AT 021022 VALEANT BERMUDA
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