Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021201
Company: CHEMISCH FBRK KRSSLR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASCLERA POLIDOCANOL 10MG/2ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes No
ASCLERA POLIDOCANOL 20MG/2ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
03/30/2010 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021201s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021201s000_Sumr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf

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