ANDA 209734

STRIDES PHARMA

FDA Drug Application

Application #209734

Documents

• Letter: 2017-11-27

Application Sponsors

ANDA 209734

STRIDES PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	125MG	0	ACETAZOLAMIDE	ACETAZOLAMIDE
002	TABLET;ORAL	250MG	0	ACETAZOLAMIDE	ACETAZOLAMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)