ANDA 209464

ZYDUS PHARMS USA INC

FDA Drug Application

Application #209464

Documents

• Letter: 2020-03-17

Application Sponsors

ANDA 209464

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

10MG

0

LORCASERIN HYDROCHLORIDE

LORCASERIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209464
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORCASERIN HYDROCHLORIDE","activeIngredients":"LORCASERIN HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209464Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-02
        )

)