ANDA 076858

RISING

FDA Drug Application

Application #076858

Documents

• Letter: 2004-09-24

Application Sponsors

ANDA 076858

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

330MG

0

LEVOCARNITINE

LEVOCARNITINE

FDA Submissions

	ORIG	1	AP	2004-09-20
LABELING; Labeling	SUPPL	6	AP	2015-11-17	STANDARD

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76858
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCARNITINE","activeIngredients":"LEVOCARNITINE","strength":"330MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOCARNITINE","submission":"LEVOCARNITINE","actionType":"330MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)