ANDA 216624

ACCORD HLTHCARE

FDA Drug Application

Application #216624

Application Sponsors

ANDA 216624

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	0.4MG/ML	0	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE
002	INJECTABLE;INJECTION	1MG/ML	0	NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216624
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-26
        )

)