Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021022
Company: VALEANT BERMUDA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENLAC CICLOPIROX 8% SOLUTION;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
12/17/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022LBLB.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf
12/22/2003 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf
06/09/2003 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf
02/09/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf
12/22/2003 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf
06/09/2003 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf
12/17/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf

PENLAC

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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