ANDA 208513

SHILPA MEDICARE LTD

FDA Drug Application

Application #208513

Application Sponsors

ANDA 208513

SHILPA MEDICARE LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

SHILPA MEDICARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208513
            [companyName] => SHILPA MEDICARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-15
        )

)