ANDA 215002

ALVOGEN

FDA Drug Application

Application #215002

Application Sponsors

ANDA 215002

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG;25MG

0

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215002
            [companyName] => ALVOGEN
            [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\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-20
        )

)