ANDA 205897

PANACEA BIOTEC LTD

FDA Drug Application

Application #205897

Documents

• Letter: 2017-10-19

Application Sponsors

ANDA 205897

PANACEA BIOTEC LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	PRASUGREL	PRASUGREL HYDROCHLORIDE
002	TABLET;ORAL	EQ 10MG BASE	0	PRASUGREL	PRASUGREL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PANACEA BIOTEC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205897
            [companyName] => PANACEA BIOTEC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRASUGREL","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRASUGREL","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205897Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-16
        )

)