ANDA 075613

INVATECH

FDA Drug Application

Application #075613

Documents

• Letter: 2000-10-10
• Review: 2001-12-05
• Other Important Information from FDA: 2005-07-28

Application Sponsors

ANDA 075613

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	100MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE
002	TABLET;ORAL	75MG	0	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2000-10-10

Submissions Property Types

ORIG

1

Null

0

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75613
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUPROPION HYDROCHLORIDE","submission":"BUPROPION HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)