ANDA 215924

TORRENT

FDA Drug Application

Application #215924

Documents

• Letter: 2023-01-10

Application Sponsors

ANDA 215924

TORRENT

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

DICHLORPHENAMIDE

DICHLORPHENAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215924
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICHLORPHENAMIDE","activeIngredients":"DICHLORPHENAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-29
        )

)