ANDA 208516

SUNNY PHARMTECH INC

FDA Drug Application

Application #208516

Application Sponsors

ANDA 208516

SUNNY PHARMTECH INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG;25MG

0

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

SUNNY PHARMTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208516
            [companyName] => SUNNY PHARMTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN (MONOHYDRATE\/MACROCRYSTALS)","activeIngredients":"NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE","strength":"75MG;25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-24
        )

)