ANDA 208381

SUN PHARM

FDA Drug Application

Application #208381

Application Sponsors

ANDA 208381

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

1250MG/5ML (250MG/ML)

0

HYDROXYPROGESTERONE CAPROATE

HYDROXYPROGESTERONE CAPROATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP1

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208381
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYPROGESTERONE CAPROATE","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"1250MG\/5ML (250MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-09
        )

)