STRIDES PHARMA FDA Approval ANDA 209734

ANDA 209734

STRIDES PHARMA

FDA Drug Application

Application #209734

Documents

Letter2017-11-27

Application Sponsors

ANDA 209734STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL125MG0ACETAZOLAMIDEACETAZOLAMIDE
002TABLET;ORAL250MG0ACETAZOLAMIDEACETAZOLAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-11-20STANDARD
LABELING; LabelingSUPPL7AP2022-07-26STANDARD

Submissions Property Types

ORIG1Null7
SUPPL7Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209734
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209734Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-20
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.