ANDA 061884

SANOFI AVENTIS US

FDA Drug Application

Application #061884

Application Sponsors

ANDA 061884

SANOFI AVENTIS US

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

150MG;300MG

0

RIFAMATE

ISONIAZID; RIFAMPIN

FDA Submissions

	ORIG	1	AP	1975-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-12-09
LABELING; Labeling	SUPPL	10	AP	1999-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-08-19
LABELING; Labeling	SUPPL	15	AP	2013-07-22
LABELING; Labeling	SUPPL	17	AP	2013-07-22
LABELING; Labeling	SUPPL	18	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-09-27	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	25	Null	15

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61884
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMATE","activeIngredients":"ISONIAZID; RIFAMPIN","strength":"150MG;300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIFAMATE","submission":"ISONIAZID; RIFAMPIN","actionType":"150MG;300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)