ANDA 213917

GLAND PHARMA LTD

FDA Drug Application

Application #213917

Application Sponsors

ANDA 213917

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	2GM/50ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE
002	INJECTABLE;INJECTION	4GM/100ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213917
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"2GM\/50ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/100ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-10
        )

)