Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022351
Company: AR HOLDING CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLCRYS COLCHICINE 0.6MG TABLET; ORAL Prescription None TBD 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
07/30/2009 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022351s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351_colcrys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351s000_SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf

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