ANDA 204144

ANCHEN PHARMS

FDA Drug Application

Application #204144

Application Sponsors

ANDA 204144

ANCHEN PHARMS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG; EQ 50MG BASE	0	METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
002	TABLET, EXTENDED RELEASE;ORAL	1GM; EQ 50MG BASE	0	METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
003	TABLET, EXTENDED RELEASE;ORAL	1GM; EQ 100MG BASE	0	METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-04-21

Submissions Property Types

ORIG

1

Null

1

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204144
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"500MG; EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"1GM; EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE","activeIngredients":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","strength":"1GM; EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-21
        )

)