ANDA 090534

AM REGENT

FDA Drug Application

Application #090534

Application Sponsors

ANDA 090534

AM REGENT

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
LABELING; Labeling	SUPPL	3	AP	2015-06-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90534
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICARDIPINE HYDROCHLORIDE","submission":"NICARDIPINE HYDROCHLORIDE","actionType":"25MG\/10ML (2.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)