ANDA 077751

ZYDUS PHARMS USA

FDA Drug Application

Application #077751

Application Sponsors

ANDA 077751

ZYDUS PHARMS USA

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

	ORIG	1	AP	2008-04-30
LABELING; Labeling	SUPPL	2	AP	2011-07-25
LABELING; Labeling	SUPPL	5	AP	2012-03-26
LABELING; Labeling	SUPPL	10	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7

TE Codes

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

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77751
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","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":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)