Back to FDA Applications sponsored by VALEANT BERMUDA

FDA Drug Application 021022 by VALEANT BERMUDA

Application Number021022
Application Type New Drug Application
Sponsor ApplicantVALEANT BERMUDA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/17/1999N931000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf 12/17/1999
AP012/17/1999N932000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf 12/17/1999
AP012/17/1999N3138000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm 12/17/1999
AP012/17/1999N3139000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022LBLB.PDF 12/17/1999
AP02/9/2001SCP       
AP06/9/2003SLR5971002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf 6/22/2003
AP06/9/2003SLR5989002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf 6/22/2003
AP012/22/2003SLR7420003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf 12/24/2003
AP012/22/2003SLR7437003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf 12/29/2003
AP012/3/2004SLR10758004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf 12/8/2004
AP012/3/2004SLR10759004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf 12/8/2004




Back to FDA Applications sponsored by VALEANT BERMUDA