Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022500
Company: ATHENA

• Summary Review

Products on NDA 022500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXICLON XR	CLONIDINE	EQ 0.17MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	No	No
NEXICLON XR	CLONIDINE	EQ 0.26MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022500lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500_clonidine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2010	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022500s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001ltr.pdf

Labels for NDA 022500

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2010	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022500s001lbl.pdf
12/03/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022500lbl.pdf