ANDA 091404

ACS DOBFAR

FDA Drug Application

Application #091404

Application Sponsors

ANDA 091404

ACS DOBFAR

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	500MG/VIAL	0	MEROPENEM	MEROPENEM
002	INJECTABLE;INJECTION	1GM/VIAL	0	MEROPENEM	MEROPENEM

FDA Submissions

	ORIG	1	AP	2011-10-26
LABELING; Labeling	SUPPL	4	AP	2015-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-11-10
LABELING; Labeling	SUPPL	8	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-07-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-07-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-07-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-07-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-07-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	0
SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	20	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91404
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEROPENEM","submission":"MEROPENEM","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MEROPENEM","submission":"MEROPENEM","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)