ALEMBIC PHARMS LTD FDA Approval ANDA 210173

ANDA 210173

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210173

Documents

Letter2018-10-15

Application Sponsors

ANDA 210173ALEMBIC PHARMS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

FDA Submissions

UNKNOWN; ORIG1TA2018-09-12STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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