ANDA 214693

UNICHEM LABS LTD

FDA Drug Application

Application #214693

Application Sponsors

ANDA 214693

UNICHEM LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE
002	TABLET;ORAL	EQ 50MG BASE	0	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE
003	TABLET;ORAL	EQ 100MG BASE	0	SITAGLIPTIN PHOSPHATE	SITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214693
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)