ANDA 065328

ACS DOBFAR

FDA Drug Application

Application #065328

Documents

• Other Important Information from FDA: 2008-09-19

Application Sponsors

ANDA 065328

ACS DOBFAR

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

CEFTRIAXONE

CEFTRIAXONE SODIUM

FDA Submissions

	ORIG	1	AP	2008-07-24
LABELING; Labeling	SUPPL	2	AP	2009-12-29
LABELING; Labeling	SUPPL	3	AP	2010-01-04
LABELING; Labeling	SUPPL	4	AP	2010-01-04
LABELING; Labeling	SUPPL	5	AP	2011-09-30
LABELING; Labeling	SUPPL	7	AP	2012-08-24
LABELING; Labeling	SUPPL	8	AP	2011-08-04
LABELING; Labeling	SUPPL	9	AP	2013-03-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-11-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-03-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-01-13	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	16	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65328
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)