ANDA 202738

MYLAN PHARMS INC

FDA Drug Application

Application #202738

Documents

• Letter: 2016-03-04

Application Sponsors

ANDA 202738

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

100MG

0

RITONAVIR

RITONAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-03-02

Submissions Property Types

ORIG

1

Null

19

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202738
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RITONAVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202738Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-02
        )

)