ANDA 204950

PAR STERILE PRODUCTS

FDA Drug Application

Application #204950

Application Sponsors

ANDA 204950

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

GANCICLOVIR SODIUM

GANCICLOVIR SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-06-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204950
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANCICLOVIR SODIUM","activeIngredients":"GANCICLOVIR SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-08
        )

)