ANDA 078648

AVANTHI INC

FDA Drug Application

Application #078648

Documents

• Letter: 2013-03-01
• Label: 2014-01-14

Application Sponsors

ANDA 078648

AVANTHI INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

6MG;120MG

0

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

ORIG

1

AP

2013-02-27

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AVANTHI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78648
            [companyName] => AVANTHI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE","activeIngredients":"DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE","strength":"6MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/27\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/078648Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE","submission":"DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE","actionType":"6MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-02-27
        )

)