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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021744
Company: DEPOMED INC

Medication Guide

Medication Guide

Products on NDA 021744

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROQUIN XR	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021744

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2005	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021744lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021744ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021744s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2011	SUPPL-19	Labeling		Label is not available on this site.
02/25/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021744s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021744s016ltr.pdf
12/29/2010	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021744s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021744s014ltr.pdf
05/07/2009	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021744s013ltr.pdf
04/27/2009	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021744s012lbl.pdf
10/17/2008	SUPPL-10		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s007,s010ltr.pdf
10/03/2008	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021744s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s008ltr.pdf
10/17/2008	SUPPL-7		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021744s007,s010ltr.pdf
09/04/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021744s005ltr.pdf
08/10/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s004lbl.pdf
08/01/2007	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021744s003ltr.pdf
08/17/2006	SUPPL-2	Manufacturing (CMC)-Expiration Date	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021744s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021744s002LTR.pdf

Labels for NDA 021744

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021744s016lbl.pdf
12/29/2010	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021744s014lbl.pdf
04/27/2009	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021744s012lbl.pdf
10/03/2008	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021744s008lbl.pdf
09/04/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s005lbl.pdf
08/10/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s004lbl.pdf
08/01/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021744s003lbl.pdf
08/17/2006	SUPPL-2	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021744s002lbl.pdf
05/19/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021744lbl.pdf

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