ANDA 070033

PLIVA

FDA Drug Application

Application #070033

Application Sponsors

ANDA 070033

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

METRONIDAZOLE

METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	1984-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-04-22
LABELING; Labeling	SUPPL	10	AP	1989-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-10-12
LABELING; Labeling	SUPPL	12	AP	1992-09-01
LABELING; Labeling	SUPPL	13	AP	1993-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-05-11
LABELING; Labeling	SUPPL	15	AP	1997-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-05-29
LABELING; Labeling	SUPPL	28	AP	2007-10-25
LABELING; Labeling	SUPPL	35	AP	2010-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2014-12-24
LABELING; Labeling	SUPPL	41	AP	2014-07-21	STANDARD
LABELING; Labeling	SUPPL	42	AP	2017-09-05	STANDARD
LABELING; Labeling	SUPPL	43	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	44	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	47	AP	2022-03-22	STANDARD
LABELING; Labeling	SUPPL	51	AP	2022-03-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	37	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	15
SUPPL	43	Null	15
SUPPL	44	Null	15
SUPPL	47	Null	15
SUPPL	51	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70033
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METRONIDAZOLE","submission":"METRONIDAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)