ANDA 201355

NOSTRUM LABS INC

FDA Drug Application

Application #201355

Documents

• Review: 2021-12-20

Application Sponsors

ANDA 201355

NOSTRUM LABS INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

25MG/5ML

0

NITROFURANTOIN

NITROFURANTOIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-08-14
LABELING; Labeling	SUPPL	3	AP	2016-09-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201355
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/28\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/25\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-09-28
        )

)