SUNNY PHARMTECH INC FDA Approval ANDA 209060

ANDA 209060

SUNNY PHARMTECH INC

FDA Drug Application

Application #209060

Documents

Letter2018-12-20

Application Sponsors

ANDA 209060SUNNY PHARMTECH INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL500MG0AMINOCAPROIC ACIDAMINOCAPROIC ACID
002TABLET;ORAL1GM0AMINOCAPROIC ACIDAMINOCAPROIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2018-11-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

SUNNY PHARMTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209060
            [companyName] => SUNNY PHARMTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209060Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-27
        )

)

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