ANDA 091187

DR REDDYS LABS LTD

FDA Drug Application

Application #091187

Application Sponsors

ANDA 091187

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE; INJECTION

4MMG

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

ORIG

1

TA

2011-09-27

Submissions Property Types

ORIG

1

Null

42

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91187
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"4MMG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"4MMG","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)