ANDA 065441

ACS DOBFAR

FDA Drug Application

Application #065441

Documents

• Other Important Information from FDA: 2008-03-21

Application Sponsors

ANDA 065441

ACS DOBFAR

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-03-20
LABELING; Labeling	SUPPL	7	AP	2011-09-29
LABELING; Labeling	SUPPL	14	AP	2013-03-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-05-25	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-05-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-05-25	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-05-25	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-05-25	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-01-03	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	7	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	26	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65441
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFEPIME HYDROCHLORIDE","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFEPIME HYDROCHLORIDE","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)