ANDA 209869

CHARTWELL RX

FDA Drug Application

Application #209869

Documents

• Letter: 2018-04-16

Application Sponsors

ANDA 209869

CHARTWELL RX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	10MG	0	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM
002	TABLET;ORAL	20MG	0	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM
003	TABLET;ORAL	40MG	0	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM
004	TABLET;ORAL	80MG	0	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-01-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

BIOCON PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209869
            [companyName] => BIOCON PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209869Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-13
        )

)