Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022353
Company: AR HOLDING CO INC

• Medication Guide

• Other Important Information from FDA

• Summary Review

Products on NDA 022353

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLCRYS	COLCHICINE	0.6MG	TABLET; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022353

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2009	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/2009/022353lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022353s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353_colcrys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353s000_SumR.pdf

Labels for NDA 022353

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf