NDA 208775

CIPLA LIMITED

FDA Drug Application

Application #208775

Application Sponsors

NDA 208775

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

120MG;60MG

0

ABACAVIR AND LAMIVUDINE

ABACAVIR; LAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2017-04-06

STANDARD

Submissions Property Types

ORIG

1

Null

2

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208775
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR AND LAMIVUDINE","activeIngredients":"ABACAVIR; LAMIVUDINE","strength":"120MG;60MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-06
        )

)