ANDA 076877

INVATECH

FDA Drug Application

Application #076877

Application Sponsors

ANDA 076877

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2006-07-06
LABELING; Labeling	SUPPL	4	AP	2014-09-24	STANDARD

Submissions Property Types

SUPPL

4

Null

7

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76877
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)