ANDA 091020

NAVINTA LLC

FDA Drug Application

Application #091020

Documents

• Letter: 2010-06-02

Application Sponsors

ANDA 091020

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

40MG/5ML

0

FAMOTIDINE

FAMOTIDINE

FDA Submissions

ORIG

1

AP

2010-05-27

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91020
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"40MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)