ANDA 209060

SUNNY PHARMTECH INC

FDA Drug Application

Application #209060

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 209060

SUNNY PHARMTECH INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	500MG	0	AMINOCAPROIC ACID	AMINOCAPROIC ACID
002	TABLET;ORAL	1GM	0	AMINOCAPROIC ACID	AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)