ANDA 202583

RISING

FDA Drug Application

Application #202583

Documents

• Letter: 2011-12-05

Application Sponsors

ANDA 202583

RISING

Marketing Status

• Prescription: 001

Application Products

001

CONCENTRATE;ORAL

100MG/5ML

0

CROMOLYN SODIUM

CROMOLYN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2011-10-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202583
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROMOLYN SODIUM","activeIngredients":"CROMOLYN SODIUM","strength":"100MG\/5ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202583s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-10-27
        )

)