ANDA 208790

ACS DOBFAR SPA

FDA Drug Application

Application #208790

Documents

• Letter: 2018-05-10

Application Sponsors

ANDA 208790

ACS DOBFAR SPA

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	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-08-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACS DOBFAR SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208790
            [companyName] => ACS DOBFAR SPA
            [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":"04\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208790Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/21\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-21
        )

)