ANDA 212040

GLAND PHARMA LTD

FDA Drug Application

Application #212040

Application Sponsors

ANDA 212040

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

EQ 1GM BASE/VIAL

0

ERTAPENEM SODIUM

ERTAPENEM SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-03-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212040
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERTAPENEM SODIUM","activeIngredients":"ERTAPENEM SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-26
        )

)