NDA 022547

CIPLA LIMITED

FDA Drug Application

Application #022547

Documents

• Letter: 2011-03-08

Application Sponsors

NDA 022547

CIPLA LIMITED

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

60MG

0

ABACAVIR SULFATE

ABACAVIR SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2011-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CIPLA LIMITED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22547
            [companyName] => CIPLA LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE","activeIngredients":"ABACAVIR SULFATE","strength":"60MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABACAVIR SULFATE","submission":"ABACAVIR SULFATE","actionType":"60MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)