Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078975
Company: AKORN
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
02/17/2010 ORIG-1 Approval

Label is not available on this site.

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 078233 ACP NIMBLE
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078046 ACTAVIS MID ATLANTIC
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078975 AKORN
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 077687 ANDA REPOSITORY
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078270 HI TECH PHARMA
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 078124 NOVAST LABS
CICLOPIROX CICLOPIROX 8% SOLUTION;TOPICAL Prescription No AT 077623 PERRIGO NEW YORK
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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