ANDA 208449

ZYDUS PHARMS USA INC

FDA Drug Application

Application #208449

Documents

• Letter: 2018-12-06

Application Sponsors

ANDA 208449

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG;500MG	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG;850MG	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	2.5MG;1GM	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-10-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

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(
    [0] => Array
        (
            [ApplNo] => 208449
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;850MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/10\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208449Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-10
        )

)