Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090490
Company: ACTAVIS MID ATLANTIC
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
11/24/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090490s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/30/2013 SUPPL-2 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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