ANDA 090884

ACS DOBFAR SPA

FDA Drug Application

Application #090884

Application Sponsors

ANDA 090884

ACS DOBFAR SPA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

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

FDA Submissions

	ORIG	1	AP	2013-04-03
LABELING; Labeling	SUPPL	2	AP	2018-01-30	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7

CDER Filings

ACS DOBFAR SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90884
            [companyName] => ACS DOBFAR SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)