ANDA 062640

ACS DOBFAR

FDA Drug Application

Application #062640

Application Sponsors

ANDA 062640

ACS DOBFAR

Marketing Status

• Discontinued: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	500MG/VIAL	0	CEFTAZIDIME	CEFTAZIDIME
002	INJECTABLE;INJECTION	1GM/VIAL	0	CEFTAZIDIME	CEFTAZIDIME
003	INJECTABLE;INJECTION	2GM/VIAL	0	CEFTAZIDIME	CEFTAZIDIME
004	INJECTABLE;INJECTION	6GM/VIAL	0	CEFTAZIDIME	CEFTAZIDIME

FDA Submissions

	ORIG	1	AP	1985-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-08-26
LABELING; Labeling	SUPPL	10	AP	1992-02-14
LABELING; Labeling	SUPPL	13	AP	1992-02-14
LABELING; Labeling	SUPPL	14	AP	1992-02-14
LABELING; Labeling	SUPPL	15	AP	1992-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-10-18
LABELING; Labeling	SUPPL	19	AP	1996-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-08-15
LABELING; Labeling	SUPPL	21	AP	1996-07-15
LABELING; Labeling	SUPPL	24	AP	2006-09-08
LABELING; Labeling	SUPPL	30	AP	2009-04-07
LABELING; Labeling	SUPPL	33	AP	2012-03-16
LABELING; Labeling	SUPPL	34	AP	2013-02-11
LABELING; Labeling	SUPPL	40	AP	2020-02-13	STANDARD
LABELING; Labeling	SUPPL	42	AP	2020-02-13	STANDARD
LABELING; Labeling	SUPPL	44	AP	2021-07-16	STANDARD
LABELING; Labeling	SUPPL	45	AP	2021-07-16	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	15
SUPPL	40	Null	15
SUPPL	42	Null	15
SUPPL	44	Null	15
SUPPL	45	Null	15

TE Codes

002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62640
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTAZIDIME","activeIngredients":"CEFTAZIDIME","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFTAZIDIME","activeIngredients":"CEFTAZIDIME","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTAZIDIME","activeIngredients":"CEFTAZIDIME","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTAZIDIME","activeIngredients":"CEFTAZIDIME","strength":"6GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTAZIDIME","submission":"CEFTAZIDIME","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFTAZIDIME","submission":"CEFTAZIDIME","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTAZIDIME","submission":"CEFTAZIDIME","actionType":"2GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTAZIDIME","submission":"CEFTAZIDIME","actionType":"6GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)