ANDA 211504

GLAND PHARMA LTD

FDA Drug Application

Application #211504

Application Sponsors

ANDA 211504

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IM-IV

1GM/10ML (100MG/ML)

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211504
            [companyName] => GLAND PHARMA LTD
            [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":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)