ANDA 211838

TORRENT

FDA Drug Application

Application #211838

Application Sponsors

ANDA 211838

TORRENT

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211838
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-28
        )

)