NDA 021744

DEPOMED INC

FDA Drug Application

Application #021744

Documents

• Letter: 2005-05-20
• Letter: 2007-08-02
• Letter: 2008-10-23
• Letter: 2008-10-23
• Letter: 2011-01-04
• Letter: 2011-03-03
• Label: 2007-08-02
• Label: 2007-08-14
• Label: 2011-01-04
• Label: 2011-03-04
• Other: 2011-01-13
• Letter: 2006-08-21
• Letter: 2007-09-06
• Letter: 2008-10-08
• Letter: 2009-05-13
• Label: 2005-05-20
• Label: 2006-08-18
• Label: 2007-09-06
• Label: 2008-10-09
• Label: 2009-05-11
• Review: 2007-09-11
• Medication Guide: 2018-02-28

Application Sponsors

NDA 021744

DEPOMED INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 500MG BASE

0

PROQUIN XR

CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2005-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2006-08-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2007-08-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-08-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2007-09-04	STANDARD
S; Supplement	SUPPL	7	AP	2008-10-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-10-03	STANDARD
S; Supplement	SUPPL	10	AP	2008-10-17	STANDARD
LABELING; Labeling	SUPPL	12	AP	2009-04-27	STANDARD
LABELING; Labeling	SUPPL	13	AP	2009-05-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2010-12-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2011-02-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	2011-08-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0

CDER Filings

DEPOMED INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21744
            [companyName] => DEPOMED INC
            [docInserts] => ["Medication Guide",""]
            [products] => [{"drugName":"PROQUIN XR","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021744s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2010","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021744s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2009","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021744s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021744s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021744s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021744s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2007","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021744s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2006","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Expiration Date","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021744s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021744lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROQUIN XR","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-02-25
        )

)