ANDA 206887

MACLEODS PHARMS LTD

FDA Drug Application

Application #206887

Application Sponsors

ANDA 206887

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206887
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-31
        )

)