ANDA 203347

HETERO LABS UNIT III

FDA Drug Application

Application #203347

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 203347

HETERO LABS UNIT III

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORAL	150MG	0	MARAVIROC	MARAVIROC
002	TABLET;ORAL	300MG	0	MARAVIROC	MARAVIROC

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-10-30

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS UNIT III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203347
            [companyName] => HETERO LABS UNIT III
            [docInserts] => ["",""]
            [products] => [{"drugName":"MARAVIROC","activeIngredients":"MARAVIROC","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MARAVIROC","activeIngredients":"MARAVIROC","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-30
        )

)