ANDA 090405

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090405

Application Sponsors

ANDA 090405

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

2.5MG

0

LETROZOLE

LETROZOLE

FDA Submissions

ORIG

1

TA

2010-01-20

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90405
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LETROZOLE","submission":"LETROZOLE","actionType":"2.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)