ANDA 065403

ACS DOBFAR

FDA Drug Application

Application #065403

Application Sponsors

ANDA 065403

ACS DOBFAR

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

0

AMPICILLIN AND SULBACTAM

AMPICILLIN SODIUM; SULBACTAM SODIUM

FDA Submissions

	ORIG	1	AP	2009-12-23
LABELING; Labeling	SUPPL	2	AP	2013-02-21
LABELING; Labeling	SUPPL	6	AP	2013-02-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65403
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN AND SULBACTAM","activeIngredients":"AMPICILLIN SODIUM; SULBACTAM SODIUM","strength":"EQ 10GM BASE\/VIAL;EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPICILLIN AND SULBACTAM","submission":"AMPICILLIN SODIUM; SULBACTAM SODIUM","actionType":"EQ 10GM BASE\/VIAL;EQ 5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)