ANDA 216603

AMNEAL

FDA Drug Application

Application #216603

Documents

• Letter: 2023-01-10

Application Sponsors

ANDA 216603

AMNEAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10MG/ML	0	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE
002	INJECTABLE;INJECTION	20MG/ML	0	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216603
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-13
        )

)