ANDA 091095

ACTAVIS LABS FL INC

FDA Drug Application

Application #091095

Application Sponsors

ANDA 091095

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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	2015-06-18
LABELING; Labeling	SUPPL	5	AP	2022-05-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91095
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NITROFURANTOIN","submission":"NITROFURANTOIN, MACROCRYSTALLINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)