ANDA 214502

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214502

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 214502

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

10MG

0

PIMAVANSERIN

PIMAVANSERIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214502
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIMAVANSERIN","activeIngredients":"PIMAVANSERIN","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214502Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-21
        )

)