ANDA 209088

AM REGENT

FDA Drug Application

Application #209088

Documents

• Letter: 2017-08-07

Application Sponsors

ANDA 209088

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

CALCIUM CHLORIDE 10%

CALCIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209088
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM CHLORIDE 10%","activeIngredients":"CALCIUM CHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209088Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-27
        )

)