ANDA 209307

GLAND PHARMA LTD

FDA Drug Application

Application #209307

Application Sponsors

ANDA 209307

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209307
            [companyName] => GLAND PHARMA LTD
            [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":"06\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-03
        )

)