ANDA 077748

COREPHARMA

FDA Drug Application

Application #077748

Application Sponsors

ANDA 077748

COREPHARMA

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	LOVASTATIN	LOVASTATIN
002	TABLET;ORAL	20MG	0	LOVASTATIN	LOVASTATIN
003	TABLET;ORAL	40MG	0	LOVASTATIN	LOVASTATIN

FDA Submissions

	ORIG	1	AP	2007-02-28
LABELING; Labeling	SUPPL	2	AP	2009-11-09
LABELING; Labeling	SUPPL	3	AP	2014-11-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-11-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-08-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-09-25	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77748
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)