ANDA 074726

UPSHER SMITH LABS

FDA Drug Application

Application #074726

Documents

• Letter: 1998-11-20
• Label: 2004-06-07
• Review: 2003-08-01
• Review: 2016-02-03
• Review: 2016-02-03
• Review: 2016-02-03
• Review: 2016-02-03

Application Sponsors

ANDA 074726

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	20MEQ	0	KLOR-CON M20	POTASSIUM CHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	KLOR-CON M10	POTASSIUM CHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	15MEQ	0	KLOR-CON M15	POTASSIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	1998-11-20
LABELING; Labeling	SUPPL	2	AP	2000-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-06-28
LABELING; Labeling	SUPPL	8	AP	2001-06-28
LABELING; Labeling	SUPPL	11	AP	2003-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2003-06-06
LABELING; Labeling	SUPPL	17	AP	2003-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-12-19
LABELING; Labeling	SUPPL	32	AP	2008-11-24
LABELING; Labeling	SUPPL	34	AP	2011-03-03

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74726
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KLOR-CON M10","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KLOR-CON M15","activeIngredients":"POTASSIUM CHLORIDE","strength":"15MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KLOR-CON M20","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/20\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74726_KLOR-CON_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KLOR-CON M10","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"KLOR-CON M15","submission":"POTASSIUM CHLORIDE","actionType":"15MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"KLOR-CON M20","submission":"POTASSIUM CHLORIDE","actionType":"20MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-11-20
        )

)