ANDA 075861

AM REGENT

FDA Drug Application

Application #075861

Documents

• Letter: 2001-06-22

Application Sponsors

ANDA 075861

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

LEVOCARNITINE

LEVOCARNITINE

FDA Submissions

	ORIG	1	AP	2001-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2022-12-15

Submissions Property Types

SUPPL

11

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75861
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCARNITINE","activeIngredients":"LEVOCARNITINE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOCARNITINE","submission":"LEVOCARNITINE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)