ANDA 213351

POLYGEN PHARMS

FDA Drug Application

Application #213351

Application Sponsors

ANDA 213351

POLYGEN PHARMS

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

2020-07-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

POLYGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213351
            [companyName] => POLYGEN PHARMS
            [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":"07\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-17
        )

)