Documents
Application Sponsors
ANDA 201355 | NOSTRUM LABS INC | |
Marketing Status
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
TE Codes
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
)
)