ANDA 210173

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210173

Documents

• Letter: 2018-10-15

Application Sponsors

ANDA 210173

ALEMBIC PHARMS LTD

Marketing Status

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-09-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210173
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN;METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"12.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN;METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"12.5MG;1000MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210173Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-12
        )

)