Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078594
Company: PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CICLOPIROX CICLOPIROX 1% SHAMPOO;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
02/16/2010 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
10/14/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

CICLOPIROX

SHAMPOO;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CICLOPIROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription No AT 090490 ACTAVIS MID ATLANTIC
CICLOPIROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription No AT 090146 FOUGERA PHARMS
CICLOPIROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription No AT 078594 PERRIGO CO
CICLOPIROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription No AT 090269 TARO
CICLOPIROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription No AT 209975 TELIGENT PHARMA INC
LOPROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription Yes AT 021159 BAUSCH

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