ANDA 206376

PRINSTON INC

FDA Drug Application

Application #206376

Application Sponsors

ANDA 206376

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 75MG BASE	0	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE
002	TABLET;ORAL	EQ 300MG BASE	0	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-03-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206376
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-24
        )

)