FRESENIUS KABI USA FDA Approval ANDA 091392

ANDA 091392

FRESENIUS KABI USA

FDA Drug Application

Application #091392

Application Sponsors

ANDA 091392FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 5MG BASE/ML0METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

ORIG1AP2013-04-19
LABELING; LabelingSUPPL3AP2019-10-30STANDARD
LABELING; LabelingSUPPL6AP2021-10-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL6Null15

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91392
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.