ANDA 205987

ACCORD HLTHCARE

FDA Drug Application

Application #205987

Application Sponsors

ANDA 205987

ACCORD HLTHCARE

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	2018-02-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205987
            [companyName] => ACCORD HLTHCARE
            [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":"02\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-04
        )

)