ANDA 091526

FRESENIUS KABI USA

FDA Drug Application

Application #091526

Documents

• Label: 2013-03-26

Application Sponsors

ANDA 091526

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-03-26

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91526
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/26\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/091526lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-03-26
        )

)