ANDA 077295

INVAGEN PHARMS

FDA Drug Application

Application #077295

Documents

• Letter: 2005-10-10

Application Sponsors

ANDA 077295

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	1MG	0	GLIMEPIRIDE	GLIMEPIRIDE
002	TABLET;ORAL	2MG	0	GLIMEPIRIDE	GLIMEPIRIDE
003	TABLET;ORAL	4MG	0	GLIMEPIRIDE	GLIMEPIRIDE

FDA Submissions

	ORIG	1	AP	2005-10-06
LABELING; Labeling	SUPPL	2	AP	2009-06-11
LABELING; Labeling	SUPPL	3	AP	2010-06-23
LABELING; Labeling	SUPPL	4	AP	2010-10-25
LABELING; Labeling	SUPPL	6	AP	2015-04-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-04-24	STANDARD

Submissions Property Types

SUPPL	3	Null	8
SUPPL	6	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77295
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)