ANDA 091641

PHARMACARE LTD

FDA Drug Application

Application #091641

Application Sponsors

ANDA 091641

PHARMACARE LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	150MG	0	ATAZANAVIR	ATAZANAVIR
002	CAPSULE;ORAL	200MG	0	ATAZANAVIR	ATAZANAVIR

FDA Submissions

ORIG

1

TA

2017-01-09

Submissions Property Types

ORIG

1

Null

1

CDER Filings

PHARMACARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91641
            [companyName] => PHARMACARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR","activeIngredients":"ATAZANAVIR","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR","activeIngredients":"ATAZANAVIR","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATAZANAVIR","submission":"ATAZANAVIR","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATAZANAVIR","submission":"ATAZANAVIR","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)