ANDA 074544

EPIC PHARMA LLC

FDA Drug Application

Application #074544

Application Sponsors

ANDA 074544

EPIC PHARMA LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
002	TABLET;ORAL	EQ 25MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
003	TABLET;ORAL	EQ 10MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
004	TABLET;ORAL	EQ 15MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM

FDA Submissions

ORIG

1

AP

1997-08-28

TE Codes

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

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74544
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEUCOVORIN CALCIUM","submission":"LEUCOVORIN CALCIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEUCOVORIN CALCIUM","submission":"LEUCOVORIN CALCIUM","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)