ANDA 208878

FRESENIUS KABI USA

FDA Drug Application

Application #208878

Documents

• Label: 2017-04-05

Application Sponsors

ANDA 208878

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208878
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208878Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208878Orig1s000lbl.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/13\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-13
        )

)