ANDA 077836

INVAGEN PHARMS

FDA Drug Application

Application #077836

Application Sponsors

ANDA 077836

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

GEMFIBROZIL

GEMFIBROZIL

FDA Submissions

	ORIG	1	AP	2006-07-27
LABELING; Labeling	SUPPL	3	AP	2010-01-11
LABELING; Labeling	SUPPL	4	AP	2010-11-23
LABELING; Labeling	SUPPL	9	AP	2016-01-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-10-02	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-10-02	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-11-26	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-08-17	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77836
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEMFIBROZIL","submission":"GEMFIBROZIL","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)