ANDA 214390

GLAND PHARMA LTD

FDA Drug Application

Application #214390

Documents

• Letter: 2022-10-17

Application Sponsors

ANDA 214390

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

CYANOCOBALAMIN

CYANOCOBALAMIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-09-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214390
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)