Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021159
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21159ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21159_Loprox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/07/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/08/2013 SUPPL-20 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021159Orig1s020ltr.pdf
12/06/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021159Orig1s019ltr.pdf
06/12/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021159s009LTR.pdf
02/26/2004 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21159scp001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/08/2013 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf
12/06/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf
06/12/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf
02/28/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf

LOPROX

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
LOPROX CICLOPIROX 1% SHAMPOO;TOPICAL Prescription Yes AT 021159 MEDICIS

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