ANDA 206071

NAVINTA LLC

FDA Drug Application

Application #206071

Documents

• Letter: 2017-11-27

Application Sponsors

ANDA 206071

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IM-IV

1GM/10ML (100MG/ML)

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206071
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;IM-IV","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206071Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-24
        )

)