ANDA 209133

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209133

Application Sponsors

ANDA 209133

AUROBINDO 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	2018-06-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-06-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-01-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2023-01-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209133
            [companyName] => AUROBINDO 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":"06\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/30\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-09
        )

)