ANDA 210002

INDOCO REMEDIES

FDA Drug Application

Application #210002

Documents

• Letter: 2019-12-30

Application Sponsors

ANDA 210002

INDOCO REMEDIES

Marketing Status

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

Application Products

001

TABLET;ORAL

6.25MG

0

ALOGLIPTIN

ALOGLIPTIN BENZOATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

INDOCO REMEDIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210002
            [companyName] => INDOCO REMEDIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210002Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)