ANDA 201722

SUN PHARM INDUSTRIES

FDA Drug Application

Application #201722

Application Sponsors

ANDA 201722

SUN PHARM INDUSTRIES

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

N/A; Not Applicable

ORIG

1

AP

2016-02-16

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201722
            [companyName] => SUN PHARM INDUSTRIES
            [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":"02\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-02-16
        )

)