ANDA 040338

AM REGENT

FDA Drug Application

Application #040338

Documents

• Letter: 2001-01-31

Application Sponsors

ANDA 040338

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

LEUCOVORIN CALCIUM PRESERVATIVE FREE

LEUCOVORIN CALCIUM

FDA Submissions

ORIG

1

AP

2001-01-31

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40338
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","submission":"LEUCOVORIN CALCIUM","actionType":"EQ 50MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)