ANDA 209662

UPSHER SMITH LABS

FDA Drug Application

Application #209662

Documents

• Letter: 2017-11-08

Application Sponsors

ANDA 209662

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

20MEQ

0

KLOR-CON

POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-04-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AA

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209662
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KLOR-CON","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209662Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/06\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-06
        )

)