ANDA 077880

AMNEAL PHARMS NY

FDA Drug Application

Application #077880

Application Sponsors

ANDA 077880

AMNEAL PHARMS NY

Marketing Status

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

Application Products

001	TABLET;ORAL	500MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	850MG	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	1GM	0	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2008-03-20
LABELING; Labeling	SUPPL	21	AP	2019-08-27	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-08-27	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	21	Null	15
SUPPL	22	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77880
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)