ANDA 211079

AMNEAL

FDA Drug Application

Application #211079

Application Sponsors

ANDA 211079

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

10MG/ML (10MG/ML)

0

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-09-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-09-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	15

TE Codes

001

Prescription

AP1

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211079
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10MG\/ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/01\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/01\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-01
        )

)