ANDA 206223

FRESENIUS KABI USA

FDA Drug Application

Application #206223

Documents

• Letter: 2018-01-17

Application Sponsors

ANDA 206223

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 2MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 5MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-01-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206223
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 2MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206223Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-16
        )

)