ANDA 204766

CIPLA

FDA Drug Application

Application #204766

Documents

• Letter: 2017-06-06

Application Sponsors

ANDA 204766

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

EFAVIRENZ

EFAVIRENZ

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-15

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204766
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204766Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-15
        )

)