ANDA 065406

ACS DOBFAR

FDA Drug Application

Application #065406

Application Sponsors

ANDA 065406

ACS DOBFAR

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	0	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	0	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM

FDA Submissions

	ORIG	1	AP	2009-12-22
LABELING; Labeling	SUPPL	7	AP	2013-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65406
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN AND SULBACTAM","activeIngredients":"AMPICILLIN SODIUM; SULBACTAM SODIUM","strength":"EQ 1GM BASE\/VIAL;EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPICILLIN AND SULBACTAM","activeIngredients":"AMPICILLIN SODIUM; SULBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL;EQ 1GM 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 1GM BASE\/VIAL;EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN AND SULBACTAM","submission":"AMPICILLIN SODIUM; SULBACTAM SODIUM","actionType":"EQ 2GM BASE\/VIAL;EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)