ANDA 074336

INVATECH

FDA Drug Application

Application #074336

Application Sponsors

ANDA 074336

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE;ORAL	25MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE
002	CAPSULE;ORAL	50MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE
003	CAPSULE;ORAL	100MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

	ORIG	1	AP	1995-01-25
LABELING; Labeling	SUPPL	2	AP	2000-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-04-19
LABELING; Labeling	SUPPL	10	AP	2022-04-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-04-08	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	15

CDER Filings

PHARMGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74336
            [companyName] => PHARMGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)