ANDA 065329

ACS DOBFAR

FDA Drug Application

Application #065329

Documents

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

Application Sponsors

ANDA 065329

ACS DOBFAR

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

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

FDA Submissions

	ORIG	1	AP	2008-07-24
LABELING; Labeling	SUPPL	2	AP	2010-01-24
LABELING; Labeling	SUPPL	4	AP	2010-11-29
LABELING; Labeling	SUPPL	6	AP	2012-05-02
LABELING; Labeling	SUPPL	7	AP	2014-11-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-03-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-01-13	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	10	Null	15
SUPPL	19	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65329
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)