ANDA 077274

EPIC PHARMA LLC

FDA Drug Application

Application #077274

Documents

• Letter: 2005-10-10

Application Sponsors

ANDA 077274

EPIC PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2007-10-01
LABELING; Labeling	SUPPL	5	AP	2009-09-21
LABELING; Labeling	SUPPL	6	AP	2010-06-23
LABELING; Labeling	SUPPL	7	AP	2010-11-18
LABELING; Labeling	SUPPL	8	AP	2017-04-17	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-05-31	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	8
SUPPL	8	Null	15
SUPPL	9	Null	7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77274
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)