ANDA 204276

PURACAP PHARM LLC

FDA Drug Application

Application #204276

Application Sponsors

ANDA 204276

PURACAP PHARM LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

50,000 IU

0

ERGOCALCIFEROL

ERGOCALCIFEROL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

PURACAP PHARM LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204276
            [companyName] => PURACAP PHARM LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERGOCALCIFEROL","activeIngredients":"ERGOCALCIFEROL","strength":"50,000 IU","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-07
        )

)