ANDA 070772

INNOGENIX

FDA Drug Application

Application #070772

Application Sponsors

ANDA 070772

INNOGENIX

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	METRONIDAZOLE	METRONIDAZOLE
002	TABLET;ORAL	500MG	0	METRONIDAZOLE	METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	1986-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-03-28
LABELING; Labeling	SUPPL	3	AP	1991-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-06-22
LABELING; Labeling	SUPPL	6	AP	1995-11-15
LABELING; Labeling	SUPPL	7	AP	1996-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-02-24
LABELING; Labeling	SUPPL	9	AP	1997-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-09-17
LABELING; Labeling	SUPPL	17	AP	2001-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-12-13
LABELING; Labeling	SUPPL	26	AP	2005-03-28
LABELING; Labeling	SUPPL	27	AP	2005-08-15
LABELING; Labeling	SUPPL	33	AP	2012-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2016-02-19	UNKNOWN
LABELING; Labeling	SUPPL	39	AP	2019-11-05	STANDARD
LABELING; Labeling	SUPPL	41	AP	2019-11-05	STANDARD
LABELING; Labeling	SUPPL	44	AP	2021-08-30	STANDARD
LABELING; Labeling	SUPPL	46	AP	2022-07-06	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	33	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	7
SUPPL	41	Null	7
SUPPL	44	Null	15
SUPPL	46	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INNOGENIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70772
            [companyName] => INNOGENIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METRONIDAZOLE","submission":"METRONIDAZOLE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METRONIDAZOLE","submission":"METRONIDAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)