ANDA 207366

NAVINTA LLC

FDA Drug Application

Application #207366

Documents

• Letter: 2016-10-14

Application Sponsors

ANDA 207366

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;INHALATION

6GM/VIAL

0

RIBAVIRIN

RIBAVIRIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-10-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AN

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207366
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIBAVIRIN","activeIngredients":"RIBAVIRIN","strength":"6GM\/VIAL","dosageForm":"FOR SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207366Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-06
        )

)