Drugs@FDA: FDA Approved Drug Products

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