ANDA 212791

SLAYBACK PHARMA LLC

FDA Drug Application

Application #212791

Application Sponsors

ANDA 212791

SLAYBACK PHARMA LLC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	0	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	0	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	0	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2021-07-22	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212791
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 200MCG BASE\/50ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 400MCG BASE\/100ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-04
        )

)