ASTRAL FDA Approval ANDA 212721

ANDA 212721

ASTRAL

FDA Drug Application

Application #212721

Application Sponsors

ANDA 212721ASTRAL

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

ASTRAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212721
            [companyName] => ASTRAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-21
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.