ANDA 202250

WATSON LABS INC

FDA Drug Application

Application #202250

Application Sponsors

ANDA 202250

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG;25MG

0

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

ORIG

1

AP

2015-07-08

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202250
            [companyName] => WATSON LABS 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":"07\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-08
        )

)