ANDA 078850

INVAGEN PHARMS

FDA Drug Application

Application #078850

Documents

• Letter: 2008-01-30

Application Sponsors

ANDA 078850

INVAGEN PHARMS

Marketing Status

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

Application Products

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

FDA Submissions

ORIG

1

TA

2008-01-29

Submissions Property Types

ORIG

1

Null

1

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78850
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"150MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"300MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)