ANDA 091516

FRESENIUS KABI USA

FDA Drug Application

Application #091516

Documents

• Letter: 2015-04-27

Application Sponsors

ANDA 091516

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

ORIG

1

AP

2015-04-23

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91516
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)