ANDA 207767

CADILA

FDA Drug Application

Application #207767

Application Sponsors

ANDA 207767

CADILA

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207767
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-25
        )

)