ANDA 090125

NAVINTA LLC

FDA Drug Application

Application #090125

Application Sponsors

ANDA 090125

NAVINTA LLC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25MG/10ML (2.5MG/ML)

0

NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2009-11-17

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90125
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICARDIPINE HYDROCHLORIDE","submission":"NICARDIPINE HYDROCHLORIDE","actionType":"25MG\/10ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)